Sections A through G Product Characteristics and Experimental Program Page 1

TITLE

Sections A through G Product Characteristics and Experimental Program

Submission for Experimental Use Permit B740

Product: Potato Late Blight Resistance Gene (also known as Rpi-vnt1)

TEST GUIDELINES:

N/A

DATE

January 30, 2014

SUBMITTED BY

J.R. Simplot Co. Plant Sciences

5369 W. Irving St., Boise, ID 83706

PAGE COUNT

Page 1 of 91
Sections A through G Product Characteristics and Experimental Program Page 2

Potato Late Blight Resistance Gene (also known as Rpi-vnt1)

Table of Contents

Section A: Chemical and Physical Properties of the Test Chemical........................................................3

Section B: Proposed Experimental Label ................................................................................................4

Section C: Toxicity Data ..........................................................................................................................6

Section D: Residue Data..........................................................................................................................6

Section E: Product Performance Information.........................................................................................6

Section F: Tolerance................................................................................................................................7

Section G: Proposed Experimental Program ..........................................................................................8

1. Participants.....................................................................................................................................8

2. Target Pest and Overview of Experimental Program .....................................................................8

3. States and Acreage .........................................................................................................................9

4. Experimental Program..................................................................................................................10

1.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Line Selection Trials (R&D).................. 10

2.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Disease Efficacy and Specificity Trials 

(Regulatory) ................................................................................................................................................ 11

3.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Environmental Risk Assessment and

Composition (Regulatory)........................................................................................................................... 12

4.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Agronomy Optimization Trials 

(Commercial) .............................................................................................................................................. 13

5.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Demonstration Trials (Commercial).... 14

5. Procedures Common to All EUP Trials ..........................................................................................15

6. Environmental Assessment of Field Trials Containing the VNT1 protein .....................................16

7. Simplot Design Protocol and Biotechnology Management Quality System Documents.............17

8. Environmental Report....................................................................................................................1
Sections A through G Product Characteristics and Experimental Program Page 3

Section A: Chemical and Physical Properties of the Test Chemical

The active ingredient is the Rpi-vnt1 gene that expresses the VNT1 protein in InnateTM 2.0 branded potato

varieties and confers resistance to the plant pathogen Phytophthora infestans, commonly known as late 

blight. The concentration of the VNT1 protein is 3.0x10-6 % by weight. The remainder of the potato would 

be considered inert as it consists of potato tuber that would not be regulated under FIFRA. Please see 

detailed submissions on Product Chemistry and Composition (885.1100, 885.1200, 885.1400) and Physical 

and Chemical Properties (830.6302, 830.6303, 830.6304). Also, please see EPA Form 8570-4 Confidential 

Statement of Formula for additional information.
Sections A through G Product Characteristics and Experimental Program Page 4

Section B: Proposed Experimental Label

Potato Late Blight Resistance Gene (also known as Rpi-vnt1)

EPA EXPERIMENTAL USE PERMIT NUMBER: 8917-EUP-R

This package contains seed for late blight resistant potatoes that contain the Rp1-vnt1 gene that expresses

the VNT1 protein with efficacy against Phytophthora infestans. The InnateTM 2.0 seed is derived from 

Russet Burbank, Ranger Russet, Atlantic, or Snowden potato varieties. 

For Experimental Use Only

For use only at an application site of a Cooperator and in accordance with the terms and conditions of 

the Experimental Use Permit (EUP). This labeling must be in the possession of the user at the time the 

potato seed is planted. Not for sale to any person other than a Participant or Cooperator of the EPAapproved Experimental Use Program.

Active Ingredient:

Rpi-vnt1 gene that expresses the VNT1 protein. 

3.0x10-6 % by weight. 

Inert Ingredient:

Potatoes are greater than 99% inert ingredients by weight.

EPA ESTABLISHMENT NO. 008917-ID-035

DISTRIBUTOR/MANUFACTURER

J.R. Simplot Company

5369 West Irving Street

Boise, Idaho 83706

NET CONTENTS: Will be shipped in various sized containers for research 

DIRECTIONS FOR USE

Use of this seed in a manner inconsistent with the terms of the Experimental Use Permit (EUP) is a 

violation of Federal law. This seed containing the Rp1-vnt1 gene expressing the VNT1 protein (plantincorporated protectant) may only be used according to the field protocols as specified in the approved 

EUP program. Cooperators must have a copy of each applicable protocol prior to initiating any research 

with these contents. Store at conditions between 45 and 50 degrees F with at least 80% humidity. This is a 

non-food EUP. No seed or potato products produced from this seed may enter the food or feed chain in 

the United States or any other country. All movement of seed shall be recorded in Record of Transport 

forms and archived by the J.R. Simplot Company to maintain chain of custody.
Sections A through G Product Characteristics and Experimental Program Page 5

STORAGE AND DISPOSAL

Storage: Store in a cool dry place. 

Pesticide disposal: Any seed not used in these experiments must be returned to the seed provider or 

disposed of using one of the following methods:

A. By treating with systemic herbicides;

B. By disking, tillage, or hand weeding in the field;

C. By deep pit burial in the field;

D. By autoclaving at 121 °C for 30 to 45 minutes;

E. By freezing;

F. By freeze drying; 

G. By grinding;

H. By composting in a restricted access area; and

I. By desiccating, crushing or burning

J. By landfill designed for permanent disposal

Container disposal: Ensure that the bag is completely empty of seeds before reuse or destroying.
Sections A through G Product Characteristics and Experimental Program Page 6

Section C: Toxicity Data

Data waivers for toxicity data are included in this EUP submission. Exact concentration of the VNT1 protein 

is unknown but is below the limit of detection of 30 ppb. Molecular characterization data show positive 

evidence of insertion of the Potato Late Blight Resistance Gene (also known as Rpi-vnt1). Other evidence 

for successful expression of the Rpi-vnt1 gene is in the RNA expression shown in the document titled:

Procedure for Analyzing Rpi-vnt1 Expression by RT-qPCR in Potato Leaf. Additionally, late blight efficacy is 

demonstrated in inoculated field trials which are discussed in Section E. Furthermore, the Potato Late 

Blight Resistance Gene (also known as Rpi-vnt1) shows approximately 90% homology with other resistance 

genes such as the tomato mosaic virus in consumed plants. A bioinformatics search showed no homology 

between the VNT1 protein and known allergens or toxins.

Section D: Residue Data

Data waivers for residue are included in this EUP submission. The level of VNT1 protein expression in 

plants containing the Potato Late Blight Resistance Gene (also known as Rpi-vnt1) is below the detection 

limit and therefore not measurable. 

Section E: Product Performance Information

Introduction

Field trials were conducted in 2012 and 2013 to test the efficacy of the Potato Late Blight Resistance Gene 

(also known as Rpi-vnt1) in InnateTM 2.0 potatoes against the US-8 and US-23 strains of late blight.

Purpose and Methods

The purpose of the study was to evaluate the foliar resistance of Potato Late Blight Resistance Gene (also 

known as Rpi-vnt1) to Phytophthora infestans (late blight) compared with the controls and commerciallyavailable reference varieties. Three field sites (Idaho, Michigan, and Pennsylvania) were planted in 

randomized complete block designs, each with four replicates. Each plot consisted of five plants spaced 

approximately 12 inches apart. Plots were bordered by a known susceptible variety such as Atlantic to 

serve as spreader rows for late blight infection. The spreader rows were inoculated with late blight at row 

closure. The following late blight strains were used: US-8 in Idaho and US-23 in Michigan and Pennsylvania. 

Plots were visually assessed for symptoms of late blight infection at regular intervals and the percentage of 

leaf area affected was recorded.

Results and Conclusions

The results of the study are presented in Table 1. The high level of infection observed in the conventional 

controls and reference varieties demonstrate the inoculation method was effective in introducing late 

blight to the field trials. The results show that the Potato Late Blight Resistance Gene (also known as Rpivnt1) was highly and significantly resistant to late blight infection compared to the controls.
Sections A through G Product Characteristics and Experimental Program Page 7

Table 1. Percent Leaf Area Affected by Late Blight Across All Sites

Lines

Percent Leaf Area

Affected by Late Blight

Final Observation

P-value

InnateTM branded

Potato Late Blight Resistance

(also known as Rpi-vnt1) 

1

0.4

p<0.0001

Controls280.9

Reference Range318.8-100.0 N/A

1N=156; includes W12, W3, W38, W8, X10, X12, X17, X19, X6, X7, Y15, Y4, and Y9

2N=36; includes Atlantic, Burbank, and Ranger

3N=48; includes Bintje, Golden Sunburst, Nicolet, and TX278

Section F: Tolerance

No tolerances are being requested as part of this EUP and therefore this section is not applicable. 
Sections A through G Product Characteristics and Experimental Program Page 8

Section G: Proposed Experimental Program

1. Participants

The experimental use program will be under the overall management of the following scientist:

Pete Clark, Ph.D.

Biotech Regulatory Manager

J.R. Simplot Co.

2. Target Pest and Overview of Experimental Program

The target pest to be evaluated in the proposed experimental program is Phytophthora infestans, an 

oomycete, the causal agent of late blight. Late blight is known to be a major pest of potatoes in North 

America and throughout the world. Late blight resistance was introduced into potato varieties by 

inserting the Potato Late Blight Resistance Gene (also known as Rpi-vnt1) through Agrobacterium

mediated transformation. The Rpi-vnt1 gene was first discovered in the wild potato species Solanum 

venturii. Late blight, which caused the Irish potato famine from 1845-1849, is still ubiquitous in the 

United States and Europe and causes extensive crop loss every year. Simplot Plant Sciences has 

transformed the Potato Late Blight Resistance Gene (also known as Rpi-vnt1) into common potato 

cultivars such as Ranger Russet and Russet Burbank, all members of the species Solanum tuberosum. 

The proposed EUP will include five studies as summarized below in Table 1. 

Table1. Proposed Field Trials for January 2014 – October 2014

Protocols Acres Lbs. of Seed

1.0 Rpi-vnt1 Late Blight Line Selection Trials (R&D): 5.50 13,750

2.0 Rpi-vnt1 Late Blight Efficacy and Specificity Trials (Regulatory): 0.75

.0

1,875

3.0 Rpi-vnt1 Late Blight Environmental Risk Assessment and Composition 

(Regulatory):

Trials:

3.50 8,750

4.0 Rpi-vnt1 Late Blight Agronomy Optimization Trials (Commercial): 66.00 165,000

5.0 Rpi-vnt1 Late Blight Demonstration Trials (Commercial): 20.00 50,000

Totals 95.75 239,375
Sections A through G Product Characteristics and Experimental Program Page 9

3. States and Acreage

A summary of proposed studies showing the acres by state is shown below in Table 2.

Table 2. Proposed Experimental Use ProgramFor Plantings From January 2014 Through October 2014

States Total Acres with Rpi-vnt1 Total Sites

ID 10.75 11

MI 6.75 8

NC 2.00 2

ND 3.00 4

NE 60.00 2

NY 2.00 2

OR 0.50 1

PA 2.75 5

WA 6.00 7

WI 2.00 2

Totals 95.75 43

In Section 4, Experimental Program, which follows, all the study designs are included for the EUP. For each 

study protocol, numbered 1-5, we have included the Objectives, Description, Vectors and Potato Varieties, 

Sites, and Acreage per Site. Following the protocols, in Section 5, we include procedures for managing the 

research that will be common to all the studies.
Sections A through G Product Characteristics and Experimental Program Page 10

4. Experimental Program

1.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Line Selection Trials (R&D)

Objective

Production of late blight resistant potatoes requires a new transformation with the vector containing 

the Potato Late Blight Resistance Gene (also known as Rpi-vnt1) for each potato variety. Following 

transformation, hundreds to thousands of plants are screened to determine the presence of the desired 

genetic insert. After that initial selection process within labs and greenhouses, approximately 100 plants 

are grown in the field for 1 or more years. These first years of field trials are used to observe the plant 

phenotype and take agronomic measurements to select those varieties expressing the trait while 

maintaining all the desired characteristics of the parent variety.

Description

Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance 

Gene (also known as Rpi-vnt1) are grown using typical agronomic practice for the geographic area. 

Plants are observed throughout the growing season, with measurements taken to determine the 

robustness and expression of desired new traits. Following one or more seasons, events are 

eliminated until only the 2-3 best performers move forward into regulatory trials. The following 

tables include the vectors and potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties

pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 1

MI 1

ND 1

OR 1

A "site" may be comprised of a research or breeding facility or a farm and the growing fields being 

utilized by such farm or facility.

Acreage per Site

Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi-vnt1): up to 

1.5 per planting.

Total acres of EUP test plants in 2014: up to 5.50 not including any required areas for buffers or 

isolation distances. 
Sections A through G Product Characteristics and Experimental Program Page 11

2.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Disease Efficacy and Specificity 

Trials (Regulatory)

Objective

The late blight efficacy trials will assess the effectiveness of late blight resistance in potatoes transformed 

with the Potato Late Blight Resistance Gene (also known as Rpi-vnt1), grown in regions of the US most 

susceptible to this disease. Trials for specificity will include testing for other common potato diseases, to 

show that the Potato Late Blight Resistance Gene (also known as Rpi-vnt1) is specific for the control of late 

blight.

Description

Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance 

Gene (also known as Rpi-vnt1) are grown using typical agronomic practice for the geographic area. 

During the growing season, when potatoes are most susceptible to late blight, potatoes plants are 

inoculated with strains of the late blight disease agent. Following inoculation, plants are observed to 

determine the response of transformed plants compared with the parental controls. The following 

tables include the vectors and potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties

pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 1

PA 1

MI 2

A "site" may be comprised of a research or breeding facility or a farm and the growing fields being 

utilized by such farm or facility.

Acreage per Site

Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi-vnt1): up to 

0.25 per planting.

Total acres of EUP test plants in 2014: up to 0.75, not including any required areas for buffers or 

isolation distances. 
Sections A through G Product Characteristics and Experimental Program Page 12

3.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Environmental Risk Assessment

and Composition (Regulatory)

Objective

Field trials will be conducted at multiple sites that represent the primary growing areas for processed 

potatoes in the US. The studies allow for agronomic and phenotypic data collection to be used in the 

Environmental and Food Safety Risk assessments required by the USDA, FDA, and EPA for biotech crop 

approval. 

Description

Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance 

Gene (also known as Rpi-vnt1) are grown using typical agronomic practice for the geographic area. 

Observations throughout the growing season will allow for an assessment of growth, pest 

susceptibility, and measurements of tuber yield and quality. Harvested potatoes will be tested for all 

major nutrients to assess the safety of food and feed. The following tables include the vectors and 

potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties

pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 2

WA 2

PA 1

ND 1

MI 1

A "site" may be comprised of a research or breeding facility or a farm and the growing fields being 

utilized by such farm or facility.

Acreage per Site

Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi-vnt1): up to 

1.0 per planting.

Total acres of EUP test plants in 2014: up to 3.50, not including any required areas for buffers or 

isolation distances. 
Sections A through G Product Characteristics and Experimental Program Page 13

4.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Agronomy Optimization Trials 

(Commercial)

Objective

The Late Blight Agronomy Optimization Trials will assess the agronomics and management considerations 

of potato events transformed with the Potato Late Blight Resistance Gene (also known as Rpi-vnt1). Trials 

will be located in multiple geographies under commercial growing conditions and will test the commercial 

viability of events and assess appropriate fungicide programs.

Description

Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance

Gene (also known as Rpi-vnt1) are grown using typical agronomic practice for the geographic area. 

Plants will be monitored throughout the growing season to assess differences in phenotype and will 

be rated for disease susceptibility. At harvest, yield, disease presence, and other agronomic data 

points will be measured to compare the transformed lines to the parental controls. The following 

tables include the vectors and potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties

pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 2

PA 2

NE 2

MI 2

A "site" may be comprised of a research or breeding facility or a farm and the growing fields being 

utilized by such farm or facility.

Acreage per Site

Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi-vnt1): up to 

60 per planting.

Total acres of EUP test plants in 2014: up to 66.00, not including any required areas for buffers or 

isolation distances. 
Sections A through G Product Characteristics and Experimental Program Page 14

5.0 Potato Late Blight Resistance Gene (also known as Rpi-vnt1) Demonstration Trials 

(Commercial)

Objective

The Late Blight Demonstration Trials will demonstrate the commercial viability of potatoes transformed 

with the Potato Late Blight Resistance Gene (also known as Rpi-vnt1).

Description

Using various experimental plot designs, potato varieties containing the Potato Late Blight Resistance 

Gene (also known as Rpi-vnt1) are grown under commercial growing conditions in multiple geographic 

areas. Plants will be monitored throughout the growing season to assess phenotype and to compare 

to commercially grown potato varieties. At harvest, yield, disease presence, and other agronomic 

data points will be measured to compare the transformed lines to the parental controls. The 

following tables include the vectors and potato varieties and summarize the number of sites by state.

Vectors and Potato Varieties

Vector Varieties

pSIM1678 Burbank W, Ranger X, Atlantic Y, Snowden V

Sites

State Number of Sites

ID 5

WA 5

ND 2

WI 2

MI 2

NY 2

NC 2

A "site" may be comprised of a research or breeding facility or a farm and the growing fields being 

utilized by such farm or facility.

Acreage per Site

Acres of EUP test plants expressing the Potato Late Blight Resistance Gene (also known as Rpi-vnt1): up to 

5 per planting.

Total acres of EUP test plants in 2014: up to 20.00 not including any required areas for buffers or isolation 

distances. 
Sections A through G Product Characteristics and Experimental Program Page 15

5. Procedures Common to All EUP Trials

Schedule

Planting dates: 1/1/14 - 6/15/14

Harvest dates: 5/1/14 –10/15/14

Managing Regulated Field Research

Simplot has adopted the Biotechnology Quality Management System sponsored by the USDA. This is a 

quality management system for regulated crops for the purpose of reducing compliance incidents and to 

have a consistent system among stakeholders. Included in this application is a subset of procedures for 

managing regulated trials (see Section 7: Simplot Design Protocol and Biotech Quality Management 

System Documents). The following steps will be followed to ensure containment of regulated potatoes 

during field trials under an Experimental Use Permit:

1) All study personnel will follow best practice documents and standard operating procedures 

implemented by the J.R. Simplot Company for the conduct of regulated field trials.

2) Simplot personnel serve as study directors and provide oversight of cooperators to ensure adherence to 

protocols, best practices, and standard operating procedures.

3) The J.R. Simplot Company will adhere to all compliance reporting requirements of each government 

agency that is regulating field trials conducted by our scientists.

The following examples below illustrate how the J.R. Simplot Company adheres to regulatory compliance 

rules and regulations.

Border rows

The EUP test plants or the trial site will be surrounded by one or more fallow border rows.

Isolation

EUP test plants will be isolated in accordance with USDA-APHIS Performance Standards for regulated 

potato trials. Trial sites of regulated potato must be spatially isolated from other cultivated potato by 

minimum isolation distance of 30-feet. The isolation area must be continuous and completely surround the 

field release site.

Sampling

Plant tissue, whole plants, and tuber samples may be taken several times during the growing season 

and sent to J.R. Simplot Co, or other laboratories for analyses.

Harvest Procedures

Plots will be harvested by hand or by machine. Regulated potato material is labeled, contained and 

transferred for storage and/or further testing after it has been harvested. 

Final Disposition

Any remaining vegetative material will be tilled into the soil or otherwise destroyed. Tuber Seed and plant 

material produced in these trials may be used for analyses or saved for further research or plantings. The 

following methods can be used to devitalize and dispose of the regulated potatoes, as applicable:
Sections A through G Product Characteristics and Experimental Program Page 16

A. By treating with systemic herbicides;

B. By disking, tillage, or hand weeding in the field;

C. By deep pit burial in the field;

D. By autoclaving at 121 °C for 30 to 45 minutes;

E. By freezing;

F. By freeze drying; 

G. By grinding;

H. By composting in a restricted access area; and

I. By desiccating, crushing or burning

J. By landfill designed for permanent disposal

Volunteer Plants

Use of GPS coordinates, stakes, markers, or other methods will be used to identify the area where the 

biotech potatoes are grown, and such an area will be subsequently monitored for volunteers for an 

appropriate period of time. Volunteers will be terminated by hand weeding, disking, spraying an

herbicide, or other method. 

6. Environmental Assessment of Field Trials Containing the VNT1 protein

The J.R. Simplot Company is requesting permission to conduct confined regulated field trials under this 

experimental use permit without requiring destruction of the crop. Potatoes are produced underground, in 

contrast to other row crops such as corn, soybeans, canola, and cotton. Because of this, it is necessary to 

let the potatoes mature and set tubers to evaluate yield and yield parameters such as grading. These yield 

and quality parameters are essential for testing the commercial potential of the potatoes. Additionally, as 

a clonally propagated crop, it takes many years to produce enough tuber seed to conduct research trials. 

Clonal propagation is required to maintain desired product characteristics and potato seed does not store 

from year to year since the tubers are approximately 80% water. To keep increasing the seed quantity, 

potatoes must be propagated from tubers produced from the previous year’s crop.

Unique aspects of potato biology support the safe conduct of field trials while minimizing environmental 

risk. As additional evidence regarding the environmental impact of potato field trials, we have included an 

Environmental Report that was written for Low Acrylamide potatoes and was submitted to the USDA (see 

Section 8: Environmental Report). For example, potatoes have relatively short distances for pollen 

movement resulting in minimal gene flow from field to field as well as the lack of wild relatives in the 

commercial potato growing regions of the United States. In short, potatoes have negligible risk of 

persisting in the environment and becoming weeds. For these reasons, it is highly unlikely that potatoes 

will escape and enter the food and feed supply or accidentally enter commerce. Therefore, we would not 

recommend crop destruction as is typical for crops under EUP B740.
Simplot Design Protocol and Biotech Quality Management System Documents Page 17

7. Simplot Design Protocol and Biotechnology Management Quality System Documents

J.R. Simplot Company Design Protocol

Performance Standards in 7CFR 340.3c

1. SHIPPING AND MAINTENANCE AT DESTINATION

 Regulated potato material (plants, tubers, and any viable material) must be double contained 

during movement/shipping to prevent unintentional release.

 Primary (inner) containers: regulated material is placed in sturdy primary containers (e.g.,

plastic or polypropylene box/bags, burlap bags, paper bags, totes, bins etcetera), capable of

containing all viable plant material.

 Secondary (outer) containers: primary containers are secured in sturdy secondary containers

(e.g., cardboard/Styrofoam boxes, plastic/wooden bins/totes, enclosed vehicles etcetera),

capable of maintaining the integrity of the regulated material during transit.

 Labeling the Shipping Container (USDA # and Contents): when shipping, the shipping container 

must be labeled with the contents and the USDA notification number. USDA notification number 

must be prominently displayed on the outermost container.

Moving Bulk Material Interstate and Intrastate: Bulk quantities of regulated material will be shipped using 

enclosed trucks or shipping containers (e.g., Reefer trailer, trucks with tight fitting tarps, etcetera).

Regulated potatoes to and from the field, storage, or testing locations will be directly loaded into

transport vehicles that are capable of containing all regulated material and do not allo w any lo ss 

to o ccur during shipm ent. The transport vehicles must be locked / closed and/or not left 

unattended, to ensure the security of the regulated material during transport. Transport vehicles used 

will be visually inspected before and after use to ensure no regulated materials are left in the 

transport vehicle. The driver and anyone handling the regulated material must report to the Simplot

Regulatory Compliance contact person immediately in case of an accidental release or breach of 

containment during shipment.

 Interstate shipments (across the States within the United States) are accompanied by a copy of

USDA movement acknowledgement letter and Record of Transport with inventory list.

 Shipments are tracked using shipping carrier’s (e.g., UPS, FedEx) tracking number or through 

electronic communication by shipper/receiver.

 Upon receipt, the receiver verifies the content of the shipment against the enclosed inventory list

and sends a copy of completed Record of Transport and inventory list to shipper for records.
Simplot Design Protocol and Biotech Quality Management System Documents Page 18

 Individual lines/clones of regulated material are clearly labeled with unique identification 

number while they are in transit or in storage.

 Storage units/areas are labeled as containing regulated material and have contact information for

emergency.

 Regulated material is segregated from non-regulated material by labeling and/or by space to avoid 

combining, contamination and/or mixing of material.

 Containers used for shipping the regulated material are disposed of or re-used after checking that 

no regulated material is left behind to avoid unintentional release.

 Personnel handling regulated material are trained in relevant aspects of storage and transport.

 Access to the regulated material is restricted to authorized personnel from the J.R. Simplot 

Company and the Collaborative Research Units.

2. INADVERTENT MIXING OF MATERIALS IN ENVIRONMENTAL RELEASE

 Regulated potatoes are planted only in the designated and well-defined field release sites, as 

mentioned in the USDA approved release notification.

 Individual lines/clones are marked in the field using unique line identification or field designation 

numbers and are noted on the plot map.

 Regulated field trials are clearly located using GPS coordinates (see Fig 1, four corners of the field or 

Northwest corner, if the trial site is very small), and are recorded on the plot map.

 Regulated potatoes planted in the field trial are flanked by a border area, ≥10-feet at the end of the

rows and ≥ 5-feet on both sides (see Fig 1) to allow containment of regulated material during

use of farm equipment, implements and/or machinery.

 The border area may be left fallow or planted with an appropriate cover crop (for example,

rye, wheat, etc.).

 There must be a minimum of ≥30-feet distance between the outer edge of the regulated trial 

and any neighboring potato field (see Fig 1), as an isolation distance for containment 

purposes. Isolation area must be maintained free of potato plants or any sexually compatible 

species throughout the growing season.

 Regulated potatoes are harvested mechanically or by hand, depending upon the availability of

farm equipment. All plant material such as border rows, guard rows, filler rows and/or plot end

spacers (for example, Red potatoes), if present, are harvested and devitalized by disking in the field, 

tillage, deep pit buried, chemical treatment, dry/steam heat, composting at Simplot or Simplot 

collaborators site, or by any other approved method.

 The entire regulated field trial, including the border area and any area exposed to regulated 

material during typical farming practices, will be monitored for volunteers in subsequent growing

seasons, as per Section 6.

 Planting and harvesting equipment and other farm implements used in the regulated trial will be

inspected and cleaned within the regulated field trial area to ensure no regulated material is 

released into the environment.

 Regulated potatoes may be planted in plastic pots, placed in plastic crates, on top of weed 

barrier cloth (“Pot Trial”). In this case, a border row is not necessary but the Pot Trial will be 

positioned at least 30-feet away from neighboring potato fields.

 Regulated potatoes harvested from these trials are experimental in nature and are completely 

under the control of the collaborative Research Unit and the J.R. Simplot Company. Access to
Simplot Design Protocol and Biotech Quality Management System Documents Page 19

regulated field trials is restricted to authorized personnel from the J.R. Simplot Company and the

Collaborative Research Unit.

 Personnel conducting field trials and handling regulated material are trained to ensure that no 

regulated material enters food or feed supply.

3. IDENTITY AND DEVITALIZATION

 Location of the regulated field trials and the individual lines/clones in the trial are marked and

recorded on a plot map, as mentioned in section 2.

 Regulated field trials are harvested or terminated on or before the expiration date of the

release notification.

 Regulated materials are harvested and stored in dedicated storage units and are identified

using unique line identification numbers. These are stored in well-defined areas in potato

storages or in constant temperature coolers at the collaborative Research Unit or at the J.R.

Simplot Company facilities and are under the control of the Collaborative Research Unit and the 

J.R. Simplot Company at all times.

 Storage units are labeled as containing regulated material and records of storage are maintained 

using electronic or paper documents.

 After biochemical, molecular, and other testing, the regulated material and/or remnants are 

devitalized by autoclaving, freezing, heating, o r anaerobic digester as detailed below, or sun

devitalized/composted, deep pit buried, chemical treatment, dry/steam heat, composting at Simplot 

or Simplot collaborators site, or by any other approved method. If the regulated article is moved to 

another approved release site location listed on the notification for devitalization; to include deep 

pit burial or disking and freezing, then field monitoring requirements for volunteers in the 

subsequent growing season is required.

Devitalization and Disposal of Regulated Potatoes using Anaerobic Digester

Introduction: Simplot Plant Sciences can use the Anaerobic Digester adjacent to the processing 

plant in Grand Forks, North Dakota to devitalize and dispose of regulated potato waste.

Disposal Method: Anaerobic Digester refers to a wastewater/waste solids treatment and biogas 

production unit that is on site at Simplot’s plant at Grand Forks, ND. Anaerobic digestion is a 

natural process, occurs in the presence of facultative and anaerobic bacteria, that converts 

biomass to methane and carbon dioxide under oxygen free conditions. The digestive process 

involves four phases:

Step 1: Hydrolysis: Large polymers are broken down by enzymes (anaerobic bacteria).

Step 2: Fermentation: Acidogenic fermentations are most important, acetate is the main end 

product. Volatile fatty acids are also produced along with carbon dioxide and hydrogen.

Step 3: Acetogenesis: Breakdown of volatile acids to acetate and hydrogen.

Step 4: Methanogenesis: Acetate, formaldehyde, hydrogen and carbon dioxide are converted to 

methane and water.

During this process the temperature is maintained at around 25°- 35°C (mesophilic range) and pH 

is close to 7. The following diagram explains the biogas process.
Simplot Design Protocol and Biotech Quality Management System Documents Page 20

At Simplot’s Biogas facility, potatoes are placed into a maceration process that crushes and blends the 

elements together to form a liquid solution (less than 40% dry matter). The solution is then sent to the 

digester (fermentation chamber), where fermentation starts as described above. Once the fermentation 

process is started, proteins, nucleic acids, fats, and carbohydrate are quickly broken down to base 

elements rendering the potatoes non-viable. The waste potato materials in the fermentation tanks of the 

biogas facility are kept for several months to ensure complete digestion. This would kill any part of the 

tuber that could have survived the crushing and mixing process.

The digested and stabilized solids from the digester are removed once annually. The digested solids will be 

used as a soil amendment. 

4. VIABLE VECTOR AGENTS

 Regulated potato plants are transformed using disarmed Agrobacterium tumefaciens.

 Transformed potato plants are freed from bacterial contamination by treatment with antibiotics

specific for Agrobacterium though multiple tissue-culture propagations, prior to either

greenhouse or field release.

5. PERSISTENCE IN THE ENVIRONMENT

 In all cases, regulated potato trials are flanked by border areas and are isolated from the 

neighboring potato fields, as mentioned in section 2.

 Regulated plant material (tubers/plant tissue/vines) left in the trial site after harvest, including 

border area plants, if present, will be devitalized by disking or deep-pit burial. Disked fields are

subjected to winter freezing and/or solar devitalization and natural decomposition.

6. VOLUNTEER PLANTS

 Field sites used for regulated potato trials will not be used for potato cultivation for two 
Simplot Design Protocol and Biotech Quality Management System Documents Page 21

subsequent growing seasons, and instead will be used for small grains or alternative crop 

production to facilitate monitoring for potato volunteers. 

 Field trials conducted using plastic containers placed on the crates above weed-barrier cloth, may

be used for subsequent field trials. However, the site will be monitored for volunteers.

 Post-harvest monitoring: Regulated trials will be harvested / terminated on or before the 

expiration of the USDA notification release date. Following the harvest/termination, the 

release site including the border area, will be monitored monthly for volunteers, when the 

environmental conditions are conducive for potato plant growth.

 Volunteers will be devitalized by disking, hand weeding, deep pit burial, chemical treatment, 

dry/steam heat, composting at Simplot or Simplot collaborators site, or by any other approved 

method

7. DATA THAT WILL BE COLLECTED

General agronomic performance data will be collected from the regulated trials, including plant 

emergence, vigor, and overall phenotype. Tuber assessments will include biochemical analyses.

Any unusual occurrences noted in the field will be immediately reported to USDA.
Simplot Design Protocol and Biotech Quality Management System Documents Page 22
Simplot Design Protocol and Biotech Quality Management System Documents Page 23

Biotechnology Quality Management System Document 7.2.1 Storage

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP) storage of the regulated material, and 

the way in which the CCP is monitored and verified.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex-1 Glossary.

3.0 RESPONSIBILITY

3.1 Permitted Party, Trial Managers, Field Supervisors, or personnel with appropriate training and 

authority.

4.0 PROCEDURE

4.1 Regulated GE organisms will be stored in dedicated storage areas or will be spatially segregated 

and separated from other organisms, if stored in the same storage area. Material in the storage 

will be managed according to the individual systems.

4.2 Designated storage areas are clearly marked and/or labeled as containing regulated GE material 

with contact information of Trial Manager for any emergency. 

4.3 If the regulated material is stored in containers, the containers are to be of durable construction 

maintaining integrity of the regulated GE organisms (e.g., temperature controlled units/rooms/ 

chambers, cardboard boxes, cabinets, totes, crates, bins, sacks, plastic boxes/bags, mesh bags, 

cloth bags, paper bags, envelopes or as appropriate for material being stored).

Long term storage: Regulated material is stored for several weeks or months. A record of storage 

(electronic or paper document) must be maintained for inventory control.

Short term storage: Regulated material is stored for less than a month (e.g., material received for 

planting, testing, etc.). Shipping records can be used as a storage record. 

4.4 If regulated material is stored in bulk, the bulk potatoes should either be in a segregated 

warehouse space with walls on all 4 sides, or segregated within a warehouse by partitions of 

suitable height such that potatoes can’t spill over. There should be sufficient isolation between 

regulated potatoes and other potatoes to avoid potential mixing. 

4.5 Regulated GE organisms are identified by labeling and/or marking the storage containers with 

unique line ID. Where possible, color coding will be used for identifying regulated GE organisms.

4.6 Access to regulated GE organisms in storage areas are limited to trained personnel authorized by 

Permitted Party or Trial Manager.
Simplot Design Protocol and Biotech Quality Management System Documents Page 24

4.7 Regulated material removed from storage for the purpose of disposal must be rendered nonviable using appropriate devitalization methods (Procedure 7.2.5).

4.8 In the event of a confirmed accidental release of regulated material, all attempts shall be made 

to recover as much of the regulated material as possible. The accidental release incident will be 

immediately documented (Procedure 7.4.1; Form 8.4.2; and Form 7.4.1) and a copy will be sent 

to SPS for taking appropriate action.

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control

Procedure 7.2.5 Devitalization and final disposition 

Procedure 7.4.1 Potential regulatory compliance incidents

Annex-1 Glossary 

5.2 Records of storage (Electronic or paper documents)

Form 7.4.1 Record of self-reporting

Form 8.4.2 Corrective/preventive action for BQMS
Simplot Design Protocol and Biotech Quality Management System Documents Page 25

Biotechnology Quality Management System Document 7.2.2 Transport and Movement, of Regulated GE 

Organisms

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP) transport, movement, and import of the 

regulated GE organism, and the way in which the CCP is monitored and verified.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex-1 Glossary. 

3.0 RESPONSIBILITY

3.1 Permitted Party, Trial Managers, Field Supervisors, or personnel with appropriate training and 

authority. 

4.0 PROCEDURE

4.1 Regulated material should be secured within a primary container capable of containing all viable 

plant material (e.g., plastic or polypropylene tube/box/bag/envelope, cloth bag, paper bag, mesh 

bag, totes, crates or as per design protocol). The primary container is placed within a secondary 

container that is able to maintain the integrity of the regulated material (e.g., large crates, bins, 

boxes, bags, totes, enclosed trucks, tarped trailers or as per design protocol for material 

containment). Multiple primary containers can be placed within a single secondary container for 

shipment.

4.2 Each shipment should be accompanied by a Record of Transport (Form 7.2.2) and a copy of 

USDA acknowledgement letter. Receiver must be informed by email/phone/fax before the 

shipment is sent. Shipments are tracked using Simplot’s regulated shipment tracking report or 

shipping carrier’s tracking number or by direct communication with the shipping carrier or 

receiver.

Note: If regulated material is shipped in bulk using semi, then the shipper must give 

instructions to the truck driver to ensure proper containment and safety of the regulated 

material during transit. All required documents must be with driver and the semi must be 

sealed and locked during transit.

4.3 Primary containers should be labeled with an identifying number or event name using printed 

labels or permanent markers. Secondary containers should be labeled: a) with applicable USDA 

movement notification number and b) address and contact details of Sender and Receiver. 

4.4 When a shipment of regulated material is received; the following actions should be taken 

immediately by the recipient (Trial Manager or others with appropriate training and authority):

a) Check and inspect the condition of shipping containers to ensure containment integrity.

b) If the shipping container(s) is/are damaged or breached, it should be immediately informed 
Simplot Design Protocol and Biotech Quality Management System Documents Page 26

to SPS for taking an appropriate action.

c) Verify the contents according to the enclosed inventory list. If, the contents don’t match the 

attached inventory list, then make a note and inform the sender to take appropriate action 

as needed. 

d) Complete the receiver section of the Record of Transport (Form 7.2.2). Place original in the 

compliance folder and send a copy to shipper and SPS for records.

e) Regulated material should be placed in a designated storage area (Procedure 7.2.1).

4.5 Primary and secondary containers used in transport or shipping of regulated material should be 

disposed or returned to use, only after making sure that no regulated GE material is left in the 

container. Any regulated GE organisms recovered after cleaning, must be rendered non-viable 

(Procedure 7.2.5). 

4.6 In the event of a confirmed accidental release of regulated material, all attempts shall be made 

to recover as much of the regulated material as possible. The accidental release incident should 

be documented (Procedure 7.4.1; Form 8.4.2; and Form 7.4.1) and a copy will be sent to 

Permitted Party to take appropriate action.

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control

Procedure 6.2.2 Competency, awareness, and training

Procedure 7.2.1 Storage

Procedure 7.2.5 Devitalization and final disposition 

Procedure 7.4.1 Potential regulatory compliance incidents

Annex-1 Glossary 

5.2 Form 6.2.2 Record of training

Form 7.2.2 Record of transport

Form 7.4.1 Record of self-reporting

Form 8.4.2 Corrective/ preventive action for BQMS

5.3 External documents

Potato Design protocol 

 USDA Permits/Notifications 
Simplot Design Protocol and Biotech Quality Management System Documents Page 27

Biotechnology Quality Management System Document 7.2.3 Environmental Release Planning and 

Monitoring

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP) environmental release planning and 

monitoring of the regulated material, and the way in which the CCP is monitored and verified. 

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex-1 Glossary.

3.0 RESPONSIBILITY

3.1 The Permitted Party, Trial Manager, Field Supervisors, or personnel with appropriate authority 

and training.

4.0 PROCEDURE

4.1 Pre-planting handling and transfer to environmental field release site:

Trial Manager must have a plot map (Record 7.2.3.d) or a layout of the trial site indicating 

surrounding land uses, isolation distances employed, and border area, where applicable, before 

transferring the regulated material to the trial site. Regulated material must be placed in secure 

containers for transfer to the trial site to avoid any potential loss of containment.

4.2 Preparation and cleaning of planting equipment:

Equipment and tools used in planting regulated field trials or used in the maintenance of the trial 

site must be inspected and cleaned on the trial site prior to their removal to eliminate 

unintended transport of regulated material from the trial site (Form 7.2.3.a).

Any regulated plant material recovered after cleaning must be rendered non-viable by using 

devitalization and disposition methods (Procedure 7.2.5).

4.3 Border markings of the environmental release site:

Four corners of the field release site will be clearly marked using physical markers and/or 

identified using GPS coordinates. Border area will be measured from the edge of the field trial, 

as per Design Protocol.

4.4 Documentation of environmental release site:

Trial Manager must prepare a plot map (Record 7.2.3.d) for each environmental field release 

site, as per acknowledged USDA permit/notification for environmental field release for the 

proposed field trial site. Plot map must provide layout of the site, separation distance employed, 

border area, as applicable, and surrounding land uses, such as adjacent field plots, buildings, 

roads, alleys, fallow zones, and natural ecosystems (water bodies, mountains, flood plains).

Trial Manager must record what is planted, date of planting, legal description or location of the 

trial site, total area planted, and GPS coordinates by completing Record of Planting (Form 
Simplot Design Protocol and Biotech Quality Management System Documents Page 28

7.2.3.a). A copy of completed Record of Planting with plot map must be submitted to SPS within 

five to ten days of planting. SPS will submit planting report to USDA before the fifteenth day of 

the month following planting. 

4.5 Monitoring of field release site for reproductive isolation:

The Trial Manager must ensure that the trial site and surrounding isolation areas are kept free of 

prohibited plants (plant species that are sexually compatible with regulated GE organisms), by 

implementing a program of regular monitoring and devitalization of any prohibited plants 

(Procedure 7.2.5). Record of Spatial Isolation (Form 7.2.3.f) must be completed, signed, and 

dated. A copy of this record should be sent to SPS after the harvest of the trial.

4.6 Harvest preparation and equipment cleaning:

Trial Manager must communicate with SPS to plan and prepare for the harvest. Record of 

Harvest (Form 7.2.3.c) is completed to document and verify the following: 1) field release site to 

be harvested, 2) harvest date and 3) cleaning of equipment and tools used for harvesting as 

mentioned above in 4.2 and send a copy to SPS within one week after harvest. SPS will submit 

the final field test report to USDA within six (6) months of trial site harvest or termination.

4.7 In-season monitoring of field release site:

The Trial Manager or designated personnel must implement in-season monitoring to ensure the 

following:

1) Proper reproductive control measures are in place to avoid the spread or escape of regulated 

GE organisms from the release site (see 4.5);

2) Monitor the release site for any deleterious effects on plants, non-target organisms, or the 

environment;

3) The release site will be monitored monthly; and

4) Monitor the release site, including alleys; border and fallow zones, for sexually compatible 

plants and/or viable plant parts or material to control the spread of the regulated GE organisms 

from the release site (see 4.5).

4.8 Post-harvest volunteer monitoring of environmental field release sites:

The post-harvest monitoring period for environmental field release site is two (2) years. 

Ownership, control, or physical access of the release site must be secured by the Trial Manager 

for post-harvest period. During this period, an alternative crop can be grown at the site to allow 

monitoring for volunteer plants.

During the post-harvest monitoring period, the Trial Manager must monitor release site, once a 

month, including border areas for volunteers (Form 7.2.3.h), and ensure that volunteer plants 

and/or viable plant parts are devitalized and rendered non-viable (Procedure 7.2.5).

At the end of each growing season of the two (2) year post-harvest period, a copy of the 

monitoring record (Form 7.2.3.h) should be sent to SPS for records.

4.9 Relevant personnel must have training applicable to their defined roles and responsibilities 

(Form 6.2.2). In the event of a confirmed accidental release of regulated material, all attempts 

shall be made to recover as much of the regulated material as possible. The accidental release 

incident will be immediately documented (Procedure 7.4.1; Form 8.4.2; and Form 7.4.1) and a 

copy will be sent to SPS to take appropriate action.
Simplot Design Protocol and Biotech Quality Management System Documents Page 29

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control

Procedure 7.2.2 Transport, movement and import of regulated GE organisms

Procedure 7.2.5 Devitalization and final disposition 

Procedure 7.4.1 Potential regulatory compliance incidents

Annex-1 Glossary

5.2 Record 5.4 Organizational chart, responsibilities, and authorities

Record 7.2.3.d Instructions for plot map

Form 6.2.2 Record of training

Form 7.2.3.a Record of planting

Form 7.2.3.f Record of spatial isolation

Form 7.2.3.c Record of harvest 

Form 7.2.3.h Record of post-harvest inspection

Form 7.4.1 Record of self-reporting

Form 8.4.2 Corrective/preventive action for BQMS

5.3 External documents

Design protocol 

Potato Growing and Confidential agreement 

 USDA Permits/Notifications 
Simplot Design Protocol and Biotech Quality Management System Documents Page 30

Biotechnology Quality Management System Document 7.2.4 Post-Harvest Handling and Transfer

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP), post-harvest handling and transfer of 

the regulated organisms, and the way in which the process is monitored and verified.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex-1 Glossary.

3.0 RESPONSIBILITY

3.1 The Permitted Party, Trial Manager, Field Supervisors, or personnel with appropriate training 

and authority.

4.0 PROCEDURE

4.1 Regulated GE organisms harvested from the field release sites must be transferred to a 

designated storage units and/or further testing locations by personnel with appropriate training 

in relevant aspects of handling and storage of regulated GE material.

4.2 Containment of the GE organisms during transfer to storage/conditioning locations.

a) Intrastate shipments: Where field release sites and storage/testing locations are within close 

proximity and/or in the same state, then the GE organisms are secured in sturdy containers 

capable of maintaining the integrity of the regulated material (bags, bins, totes, boxes, 

trucks, etc.), as appropriate, depending on the quantity being transferred. Care must be 

taken to avoid any spillage during the transport.

b) Interstate shipments (field release sites and storage/testing locations are in different states:

Follow the Procedure 7.2.2 (Form 7.2.2).

4.3 Regulated GE organisms must be clearly identified by labels indicating specific line identification 

number and/or name to distinguish from other regulated and/or non-regulated organisms 

(Procedure 7.2.1). 

4.4 Regulated GE organisms must be handled by personnel with appropriate training. The following 

steps must be taken to avoid any potential mixing with non-regulated/conventional material and 

to maintain the identity of the regulated GE organisms:

a) Ensure proper cleaning of equipment/tools used between tests.

b) Ensure that regulated waste material is segregated, devitalized, and that proper 

documentation is completed.
Simplot Design Protocol and Biotech Quality Management System Documents Page 31

4.5 Equipment and/or tools used for regulated GE organisms must be inspected and cleaned, as 

necessary before and after their use to eliminate unintended transport of regulated organisms 

from the confined area. 

4.6 Any misidentified regulated GE organisms must be rendered non-viable (Procedure 7.2.5). In the 

event of a confirmed accidental release of regulated organisms, all attempts shall be made to 

recover as much of the regulated organisms as possible and render non-viable (Procedure 7.2.5). 

The accidental release incident should be documented (Procedure 7.4.1; Form 8.4.2; and Form 

7.4.1) and a copy will be sent to Permitted Party for appropriate action to be taken.

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control

Procedure 6.2.2 Competence, awareness, and training

Procedure 7.2.1 Storage

Procedure 7.2.2 Transport, movement and import of regulated GE organisms

Procedure 7.2.5 Devitalization and final disposition

Procedure 7.4.1 Potential regulatory compliance incidents 

Annex-1 Glossary

5.2 Form 6.2.2 Record of training

Form 7.2.2 Record of transport

Form 7.2.1.c Record of material transfer and termination

Form 7.4.1 Record of self-reporting

 Form 8.4.2 Corrective/ preventive action for BQMS 
Simplot Design Protocol and Biotech Quality Management System Documents Page 32

Biotechnology Quality Management System Document 7.2.5 Devitalization and Final Disposition

1.0 PURPOSE

1.1 This procedure describes the critical control point (CCP), devitalization and final disposition of 

the regulated material, and the way in which the CCP is monitored and verified. 

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex-1 Glossary.

3.0 RESPONSIBILITY

3.1 The Quality Management Representative, Trial Managers, Field Supervisors, or personnel with 

appropriate training and authority.

4.0 PROCEDURE

4.1 Regulated plant material in the confined field release site, including border rows, that is not 

retained for research purposes must be rendered non-viable using applicable devitalization and 

disposition methods and must be documented. 

4.2 Regulated material removed from storage and/or other means of containment for the purpose 

of disposal must be rendered non-viable using applicable devitalization and disposition methods 

and must be documented. 

4.3 Methods of Devitalization and Disposition

Methods of devitalization and final disposition of regulated GE organisms may include, but is not 

limited to, the following methods as applicable:

A. By treating with systemic herbicides;

B. By disking, tillage, or hand weeding in the field;

C. By deep pit burial in the field;

D. By autoclaving at 121 °C for 30 to 45 minutes;

E. By freezing;

F. By freeze drying; 

G. By grinding;

H. By composting in a restricted access area; and

I. By desiccating, crushing or burning

J. By landfill designed for permanent disposal

4.4 Trial Manager and/or SPS must maintain the records of devitalization and final disposition 

(Procedure 4.2.4) of regulated material in the field and storage.

4.5 Devitalized regulated material will be disposed into a landfill. 
Simplot Design Protocol and Biotech Quality Management System Documents Page 33

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control

Procedure 6.2.2 Competency, awareness and training

Annex-1 Glossary

CIS website

5.2 Form 6.2.2 Record of training

Form 7.2.1.a Record of storage 

Form 7.2.1.c Record of material transfer and termination

Form 7.2.3.a Record of planting

Form 7.2.3.c Record of harvest

Form 7.2.3.h Record of post-harvest inspection

5.3 External Documents

 Potato design protocol 
Simplot Design Protocol and Biotech Quality Management System Documents Page 34

Biotechnology Quality Management System Document 7.4.1 Potential Regulatory Compliance Incidents

1.0 PURPOSE

1.1 This procedure describes the process for reporting potential regulatory compliance incidents to 

appropriate regulatory authorities for prompt incident remediation and resolution; the way in 

which the process is monitored; and whether the monitoring and verification, as well as changes 

in those activities, are effective. The species of regulated GE organism addressed in this 

procedure is potato.

2.0 DEFINITIONS

2.1 Terms and acronyms that may apply to this procedure are in Annex-1 Glossary.

3.0 RESPONSIBILITY

3.1 The Quality Management Representative, Trial Managers, Field Supervisors, or personnel with 

appropriate training and authority.

4.0 PROCEDURE

4.1 Trial Manager or relevant personnel will document any compliance incidents discovered and 

communicate immediately to SPS QMR by phone, e-mail or fax, explaining the nature and type 

of the incident occurred. 

4.2 Trial Manager or relevant personnel responsible must document the compliance incident 

discovered by completing the Record of Self-reporting (Form 7.4.1) and fax or e-mail a copy to 

SPS QMR for resolution. The flow chart in Figure 1, explains the process for self-reporting 

compliance incidents and resolution of compliance incidents.

4.3 SPS QMR upon receiving the incident report from Trial Manager or relevant personnel will 

review the incident internally. In the event that QMR confirms that an accidental release has 

occurred, the QMR will then notify USDA/APHIS for appropriate action as described in the flow 

chart Figure 1.

4.4 In the event of a confirmed accidental release of regulated material at any stage, all attempts 

shall be made to recover as much of the regulated material as possible. If needed, all recovered 

regulated material must be devitalized as appropriate (Procedure 7.2.5). The period of 

monitoring of the incident site will be determined in consultation with USDA/APHIS. 

4.5 APHIS web site for instructions for compliance incidents:

http://www.aphis.usda.gov/biotechnology/compliance_incident.shtml

4.6 SPS QMR or designee will ensure that relevant personnel involved in regulatory compliance 

incidence reports are adequately trained in the relevant aspects (Procedure 6.2.2; Form 6.2.2). 

SPS QMR will ensure that the training is implemented and effective by interviews, site visits, 
Simplot Design Protocol and Biotech Quality Management System Documents Page 35

audits, and/or other monitoring activities (Procedure 8.2.1; Form 8.2.1; Form 8.2.1.a). The 

effectiveness of implementation is measured by number of compliance incidents reported.

4.7 Records will be kept on all the above activities according to Procedure 4.2.4.

5.0 REFERENCES

5.1 Procedure 4.2.3 Document control

Procedure 4.2.4 Record control

Procedure 6.2.2 Compliance, awareness, and training

Procedure 7.2.5 Devitalization and final disposition 

Procedure 8.2.1 Internal audit

Annex-1 Glossary

CIS website

5.2 Form 6.2.2 Record of training

Form 8.2.1 Internal audit report and checklist

Form 8.2.1.a Site inspection checklist

Form 7.4.1 Record of self-reporting
Simplot Design Protocol and Biotech Quality Management System Documents Page 36 Field Operations Discovers Potential Compliance Incident Incident is Reported to SPS Incident Reportable

SPS take action internally and communicate appropriate action

Yes No Type of Unauthorized Incident

Report within 24 hr Immediate to APHIS and Field Operations

Report within 5 Days to APHIS Substantially Difference Occurrence

Obtain Required Information

Resolution of Incident Procedure 7.2.7

Notice of Compliance Notice of Non- Compliance Notice of Non- Compliance with Additional Actions

APHIS Response

Closed

Remedial Action Taken Closed by APHIS

Figure 1: SPS Regulatory Compliance Incident Reporting Flow Chart.
Environmental Report Page 1

8. Environmental Report

Environmental Report in Support of

Petition for Determination of Nonregulated Status for InnateTM Potatoes with Low Acrylamide Potential 

and Reduced Black Spot Bruise: Events E12 and E24 (Russet Burbank); F10 and F37 (Ranger Russet); J3, 

J55, and J78 (Atlantic); G11 (G); H37and H50 (H)

Prepared by Pete Clark Ph.D. and Susan Collinge Ph.D.

J.R. Simplot Company

March 1, 2013

Complementary to J.R. Simplot Company Petition JRS01 (USDA Petition 13-022-01p)

OECD Unique identifiers:

SPS-F10-7

SPS-F37-7

SPS-E12-8

SPS-E24-2

SPS-J3-4

SPS-J55-2

SPS-J78-7

SPS-G11-9

SPS-H37-9

SPS-H50-4
Environmental Report Page 2

Table of Contents of Environmental Report

1. Purpose and Need.......................................................................................................................... 5

1.1. Purpose of Product .......................................................................................................................5

1.2. Action............................................................................................................................................6

1.3. Action Area....................................................................................................................................6

2. Affected Environment.................................................................................................................... 8

2.1. Potato Products and Consumption...............................................................................................8

2.2. Agricultural Production of Potatoes .............................................................................................8

2.3. Physical Environment..................................................................................................................16

2.4. Biological Resources....................................................................................................................18

2.5. Human Health.............................................................................................................................24

2.6. Livestock Health Considerations.................................................................................................25

2.7. Socioeconomic Considerations...................................................................................................26

3. Alternatives.................................................................................................................................. 28

3.1. Alternative I: No Action...............................................................................................................28

3.2. Alternative II: Approval of Petition in Whole..............................................................................29

3.3. Comparison of Alternatives ........................................................................................................29

4. Environmental Consequences ..................................................................................................... 31

4.1. Scope of Analysis.........................................................................................................................31

4.2. Agricultural Production of Potatoes ...........................................................................................31

4.3. Physical Environment..................................................................................................................33

4.4. Biological Resources....................................................................................................................35

4.5. Human Health.............................................................................................................................38

4.6. Animal Feed ................................................................................................................................39

4.7. Socioeconomic Impacts ..............................................................................................................40

5. CUMULATIVE IMPACTS ................................................................................................................ 42

5.1. Assumptions Used for Cumulative Impacts Discussion ..............................................................42

5.2. Cumulative Impacts: Land Use....................................................................................................42

5.3. Cumulative Impacts: General Agronomic Practices....................................................................43

5.4. Cumulative Impacts: Organic Production Practices....................................................................43

5.5. Cumulative Impacts: Water Resources.......................................................................................43

5.6. Cumulative Impacts: Soil Quality ................................................................................................43

5.7. Cumulative Impacts: Air Quality .................................................................................................44

5.8. Cumulative Impacts: Climate Change .........................................................................................44

5.9. Cumulative Impacts: Animal Communities.................................................................................44

5.10. Cumulative Impacts: Plant Communities, Gene Flow, and Weediness..................................44

5.11. Cumulative Impacts: Microorganisms ....................................................................................45

5.12. Cumulative Impacts: Biodiversity............................................................................................45

5.13. Cumulative Impacts: Consumer Health ..................................................................................45

5.14. Cumulative Impacts: Worker Safety .......................................................................................46

5.15. Cumulative Impacts: Animal Feed (Livestock Health).............................................................46

5.16. Cumulative Impacts: Domestic Economic Environment.........................................................46

5.17. Cumulative Impacts: Trade (International) Economic Environment ......................................47

6. References ................................................................................................................................... 48
Environmental Report Page 3

LIST OF TABLES

Table 1. Events and Their OECD Unique Qualifier.

Table 2. Recipient Potato Material.

Table 3. U.S. 2010 Potato Harvest by State.

Table 4. U.S. Potato Harvests by Seasonal Group, 2009.

Table 5. Common Potato Disease and Insect Symptoms

Table 6. U.S. Per Capita Potato Consumption 2012 (Pounds).

Table 7. U.S. 2010 Potato Utilization.

Table 8. Summary of Potential Impacts.

LIST OF FIGURES

Figure 1. Potato Production by State: 2010.

Figure 2. Potato Production in the United States (proximity to wild spp.): 2011.

Acronyms and Abbreviations

APHIS Animal and Plant Health Inspection Service

ARS Agricultural Research Service (within USDA)

BRS Biotechnology Regulatory Services (within USDA–APHIS)

CAA Clean Air Act

CEQ Council on Environmental Quality

CFR Code of Federal Regulations (United States)

CWT 100 pounds

DNA deoxyribonucleic acid

EA Environmental Assessment

EPTC S-Ethyl dipropylthiocarbamate, a herbicide

ERS Economic Research Service (within USDA)

FAO Food and Agricultural Organization of the United Nations

GWP Global warming potential

IPD Inter-genebank Potato Database

NASS National Agricultural Statistic Service (within USDA)

NEPA National Environmental Policy Act

NOP National Organic Program

NPC National Potato Council

NSF National Science Foundation
Environmental Report Page 4

Acronyms and Abbreviations

OECD Organization for Economic Co-Operation and Development

PAA Potato Association of America

PPRA Plant Pest Risk Assessment

TPS True Potato Seed

USDA US Department of Agriculture

USDHH US Department of Health and Human Services

US EPA US Environmental Protection Agency

US FWS US Fish and Wildlife Service

WPS Worker Protection Standards
Environmental Report Page 5

1. Purpose and Need

 

1.1. Purpose of Product

Simplot has developed potato events with low acrylamide potential and reduced tendency for black spot 

bruise to meet expected market demand. The InnateTM branded proprietary potatoes have been 

developed through the utilization of biotechnology transformation methods that use primarily potato 

DNA (Collinge and Clark 2013). The reasons for the market demand are described below. 

The FDA has not issued guidance to manufacturers, and its general advice regarding acrylamide is for 

consumers to adopt a diet consistent with the Dietary Guidelines for Americans (USDA USDHHS 2010). 

The FDA is considering issuing guidance for the industry on reduction of acrylamide levels in food 

products (US FDA 2009 p. 2). The introduction of potatoes with low acrylamide potential would provide 

potatoes that are substantially equivalent to existing varieties, except for the intended differences.

Acrylamide, a naturally-occurring substance that forms primarily in carbohydrate-rich food cooked to 

temperatures over 250 degrees Fahrenheit (involves a Maillard reaction), has been in the human diet for 

many thousands of years according to the U.S. Environmental Protection Agency and the U.S. Food and 

Drug Administration (US EPA 2010 p. 6, US FDA 2009). It is found in french fries and chips, breads and 

bakery products, cereals and muesli, crackers and snack food, gravies and seasoning, nuts and nut 

butter, chocolate, canned fruits and vegetables, coffee and other foods (US EPA 2010 p. 7, US-FDA 

2006). Because of concerns about the potential human health effects of acrylamide, there have been 

international efforts to reduce acrylamide levels in food since reports about its presence in food in 2002 

(US-FDA 2009 p. 2).

Acrylamide forms in foods primarily from a reaction between certain sugars such as glucose and fructose 

(reducing sugars) and asparagine (an amino acid) that are naturally present in food (US FDA 2009 p. 2). 

For potatoes, mitigation measures have focused on 1) controlling levels of sugar and/or asparagine in 

the potatoes and 2) modifying processing and/or cooking techniques to reduce the formation of 

acrylamide (US FDA 2009 p. 4, Food Drink Europe 2011). Use of food additives such as the enzyme 

asparaginase, which breaks down asparagine, is approved in several countries including Canada and the 

U.S. (Health Canada 2012 p.1). The reduction in asparagine and sugars using InnateTM technology and the 

resulting reduction in acrylamide upon heating will address industry needs with respect to the potential 

FDA guidance.

In addition, litigation in the state of California resulted in legal settlements with restaurant chains and 

the retail french fry and potato chip manufacturers regarding acrylamide. The settlements required 

manufacturers of retail fries and potato chips to reduce the level of acrylamide in their products (State 

of California, Office of Attorney General 2008) as well as share any technology that would result in 

reduced acrylamide. Potato processors affected by these rulings in California would be motivated to 

adopt the low acrylamide potatoes. 

Demand for the low acrylamide potatoes would also be expected from consumers who are concerned 

about the levels of acrylamide in their food. The benefits resulting from the modifications could result 

in increased market share for certain varieties, such as Ranger Russet. The lower levels of reducing 

sugars and black spot bruise in the InnateTM Ranger Russet may increase the popularity of that variety. 
Environmental Report Page 6

Extensive analyses of the various events demonstrated that the achievement of the desired 

modifications was enabled by targeted gene silencing. Simplot found there to be reduced RNA 

(transcript) levels of four targeted genes in tubers, which may be associated with:

(1) 69 – 78 percent reductions in free-asparagine;

(2) Black spot bruise tolerance; and 

(3) Lower levels of reducing sugars (Collinge and Clark 2013).

The Ranger Russet variety has higher yield potential than Russet Burbank, but its market penetration is 

limited by its susceptibility to black spot bruising and senescence sweetening. It is anticipated that while 

the InnateTM potato events may enjoy significant acreage due to the potential health benefits of reduced 

acrylamide and reduced black spot, no overall significant increase in potato production acreage in the 

United States is expected.

1.2. Action

Simplot is seeking nonregulated status for the events listed in Table 1under 7 CFR part 340. Specifically, 

Simplot requests a determination from APHIS that the 10 potato events described in the petition, and 

any progeny derived from these events, are granted nonregulated status and would no longer be 

considered regulated articles under 7 CFR Part 340 (Collinge and Clark 2013).

Table 1. Events and Their OECD Unique Identifiers

Event Number OECD Unique Identifier

F10 (Ranger Russet) SPS-F10-7

F37 (Ranger Russet) SPS-F37-7

E12 (Russet Burbank) SPS-E12-8

E24 (Russet Burbank) SPS-E24-2

J3 (Atlantic) SPS-J3-4

J55 (Atlantic) SPS-J55-2

J78 (Atlantic) SPS-J78-7

G11 (“G” variety) SPS-G11-9

H37 (“H” variety) SPS-H37-9

H50 (“H” variety) SPS-H50-4

1.3. Action Area

Commercial potato production occurred on over one million acres in 2011 in 31 U.S. states across the 

continental U.S. and in Alaska (USDA NASS 2012).1 Idaho accounts for 30% of the planted acreage, and 

the eight states of Idaho, Washington, North Dakota, Wisconsin, Colorado, Maine, Minnesota and 

Michigan account for over three-quarters of the planted acreage (USDA NASS 2012). While production 

tends to be in northern states, in 2011, two southern states, Texas and Florida, each had more than 

10,000 acres harvested (USDA NASS 2012). 

 

1

In some years additional states reported small harvested acreage.
Environmental Report Page 7

Except for the reductions in free asparagine and reducing sugars and the greater tolerance to black spot 

bruising, potatoes transformed by Simplot’s InnateTM technology are substantially equivalent to their 

non-transformed counterparts. Other characteristics are not affected by the transformation process. 

Therefore, the InnateTM potatoes would be grown in the same areas and using the same techniques as 

their non-transformed counterparts. Usage and acreage characteristics of the recipient (nontransformed) potato material are summarized in Table 2 (Collinge and Clark 2013). 

Table 2. Recipient Potato Material

Variety Usage Percent of Seed Acreage in US1

Russet Burbank Fries 22.0

Ranger Russet Fries 6.3

Atlantic Chips 2.6

G Chips 2.0

H Chips 0.7

1

2009 data [National Potato Council (NPC) 2010 p. 63]
Environmental Report Page 8

2. Affected Environment

The affected environment section provides an overview of the use and composition of potatoes, 

followed by a discussion of the current conditions of those aspects of the human environment 

potentially impacted by a determination of nonregulated status of events E12, E24, F10, F37, J3, J55, 

J78, G11, H37, and H50. Potato production occurs throughout much of the U.S., although production is 

concentrated in the top ten potato producing states described below. 

2.1. Potato Products and Consumption 

Potatoes in the United States are grown in many states, although about half of the crop comes from 

Idaho and Washington. The top ten potato producing states of Idaho, Washington, Wisconsin, North 

Dakota, Colorado, Oregon, Maine, Minnesota, California and Michigan account for almost 88% of the 

United States potato crop (USDA-NASS 2012). Most potatoes are harvested in July through October. 

Only about one third of US potatoes are consumed fresh. Around 60% of annual output is processed into 

frozen products (such as frozen fries and wedges), chips, dehydrated potato and starch, while 6% is 

replanted as seed potato. Americans eat, on average, approximately 50 kg of potatoes per person per 

year (NPC 2012).

Harvested potatoes are either used for food (~93%), feed (<1%), industrial purposes (<1%) or as “seed” 

for planting (5%). The type of use is partially dependent on a variety of characteristics related to tuber 

quality. According to the National Potato Council, approximately 50% of all tubers are used for the 

combination of frozen fries, potato chips, and shoestrings (julienne cut crispy snacks), whereas 11% are 

dehydrated and <2% are canned. An additional 28% of tubers are not processed but sold as fresh 

potatoes (NPC 2010). 

Raw potato waste products (peels, out of specification raw potatoes, or other non-processed raw potato 

products) and processed discards (french fry, hash brown, etc.) are routinely incorporated into feed 

rations at livestock feedlot operations including those owned by Simplot.

2.2. Agricultural Production of Potatoes

Land Use

U.S. 2011 potato harvests by state are summarized in Table 3 (in acres) and 2011 production by state is 

shown graphically in Figure 1 (in CWT). 
Environmental Report Page 9

Table 3. U.S. 2011 Potato Harvest by State.

State Acres of Potatoes Harvested

IDAHO

WASHINGTON

NORTH DAKOTA

WISCONSIN

COLORADO

MAINE

MINNESOTA

MICHIGAN

OREGON

CALIFORNIA

FLORIDA

NEBRASKA

TEXAS

NORTH CAROLINA 

NEW YORK

MONTANA

PENNSYLVANIA

MISSOURI

ILLINOIS

VIRGINIA

KANSAS

ARIZONA

MASSACHUSETTS

MARYLAND

NEW JERSEY

OHIO

DELAWARE

ALASKA

RHODE ISLAND

319,000

160,000

77,000

62,500

58,300

54,000

47,000

44,000

39,900

36,600

35,600

19,500

18,500

16,500

16,200

11,500

7,800

7,100

6,800

5,900

5,300

3,800

2,700

2,200

1,800

1,700

1,600

720

600

Total Approximately 1,000,000

Source: USDA NASS 2012; Nevada and New Mexico not reported to protect privacy
Environmental Report Page 10

Figure 1. Potato Production by State, Thousands CWT: 2011. 

Source: USDA NASS 2012

Potato acres harvested in the U.S. have ranged between 1.0 and 1.5 million acres since 1951, with highs 

of 1.5 million in 1953, 1966 and 1967 and lows of 1.0 million in 2008, 2009 and 2010 (USDA NASS 2012). 

In most years from 1900 to 1937, more than 3 million acres were harvested, with a high of 3.9 million in 

1922 (USDA NASS 2012). While acreage has declined over the years, total production has increased. 

Total annual U.S. production has been over 400 million CWT (one CWT = 100 pounds) every year since 

1990, with a peak of 513 million CWT in 2000 (USDA NASS 2012). Per-acre yields, which averaged 

approximately 401 CWT per acre in 2010 have increased eight-fold since the early 1900s and have 

doubled since the early 1960s. For example, in 1901 approximately 2.95 million acres of potatoes were 

harvested, producing roughly 125 million CWT, or 42.4 CWT per acre. In 2010, the harvested acreage 

was a reported 1 million acres, producing about 400 million CWT, or about 401 CWT per acre (USDA 

NASS 2012). 

Recently, the bulk of potato production in the U.S. has shifted from the East and Midwest to the 

Northwest. The shift has resulted from a number of factors, including improvements in the U.S. 

transportation system, the relative decline in consumption of fresh potatoes coupled with advantages 

associated with processing potatoes in the Northwest, and changes in weather patterns (Guenthner 

2010a, p. 13). 

Potatoes are grown in agricultural areas throughout the U.S. The largest potato-growing region by far in 

the U.S. is the Snake River Plain of southern Idaho, a major agricultural area where water is available for 

irrigation, and where nearly all the Idaho crop is grown (Bechinski et al. 2001, USDA NASS 2012, National 

Atlas 2004a). In 2010, more acres were harvested in a single Idaho county in the Snake River Plain 
Environmental Report Page 11

(61,800 acres in Bingham County) than the total in all other states except Washington and North Dakota 

(USDA NASS 2012). The second-largest growing region is the Columbia Basin (another large agricultural 

area) in Washington and Oregon, where approximately 127,000 acres were harvested in 2010 (USDA 

NASS 2012, National Atlas 2004b). Other important areas (with 2010 harvested acreage in parentheses) 

are the Red River Valley, which lies between the northern borders of North Dakota and Minnesota 

(63,000)2; San Luis Valley in south central Colorado (55,000), Aroostook County in Maine (50,400), and 

the Central Sands region of Wisconsin (37,000) (USDA NASS 2012, Delahaut 2000, McDonald et al.

2003). The potato events that are the subject of this Environmental Report (ER) may be grown in any of 

the U.S. potato-growing regions.

Potatoes grown commercially are actually clones, produced vegetatively by tuber cuttings (the lateral 

buds or "eyes") rather than by the true botanical seed (NSF 2011). These vegetative cuttings used to 

produce commercial crops are called “seed potatoes.” Approximately 6 percent of the annual potato 

crop is used as seed (USDA NASS 2011, p. 7). Certified seed potatoes are produced for the purpose of 

ensuring genetic purity and the reduction of disease introduction (NPC 2010). Most seed that is sold is 

labeled certified seed (USDA 2000, PPA 2011b, Davidson 2010 pp. 43-44; Bechinski et al. 2001, p. 2). 

There are 16 potato seed certification agencies in the U.S., including one in each major production state 

and many in other production states (NPC 2010). Seed potatoes are grown in the same areas where 

potatoes for commercial production are grown, although the areas of maximum seed production are 

often different from the areas of maximum commercial production (e.g., Delahaut 2000, Oregon State 

University 2008). Much of Maine’s potato production is for seed potatoes to supply the east coast 

(Maine Potato Board 2001, p. 12). Major seed production states in 2009 in order of decreasing 

production were Idaho, Washington, North Dakota, Colorado, Wisconsin, Maine and Michigan (USDA 

NASS 2011, p. 11). 

General Agronomic Practices 

USDA classifies potato production by season, according to the period when the largest supplies are 

harvested, as summarized in Table 4. Winter, spring and summer potatoes are harvested while the 

vines are still green and the tubers comparatively immature. These potatoes go directly from the field 

to fresh markets or into processing. Fall potatoes are usually harvested when the vines and tubers are 

mature. The mature potatoes are usually higher in dry matter, which makes them better for most 

processing. The mature fall potatoes also have tougher skins, which makes them easier to handle 

(Johnson 2010 p. 75). A large percentage of the fall crop is stored for processing and fresh market 

through the winter, spring and summer months. Many modern storage facilities are equipped with 

temperature, humidity, and forced-air ventilation control. Capacity can range from 500 tons to over 

20,000 tons (Olsen 2010 p. 81).

Table 4. U.S. Potato Harvests by Seasonal Group, 2009

Seasonal 

Group Planted Harvested

Acres 

Harvested 

(1,000)

Primary States

Average

Yield, 

CWT/acre

Winter AugustDecember

January -

March 8.7 CA only 245

Spring DecemberMarch April – June 73.7 CA, FL 289

 

2

2009 harvested acreage; 2010 not available for North Dakota.
Environmental Report Page 12

Summer March-June July – MidSeptember 44.4 11 states, all < 

8,500 acres ea. 351

Fall March-June July -

November 917.2

ID, WA, ND, 

WI, CO, ME, 

MN, MT, OR

429

Sources: USDA NASS 2011; Voss 2004; Bechinski et al. 2001 p. 2; USDA 2000, p. 1; McDonald et al. 2003, 

p. 1.

Cultivation

Potatoes typically require high levels of soil cultivation (Hopkins et al. 2004, p. 10). Cultivation of the soil 

is used for weed control, aeration, shaping beds, maintaining proper seed depth and establishing 

irrigation furrows (Bechinski et al. 2001, p. 2; Sieczka 2010 p. 53). Potato production is generally less 

conducive to maintaining healthy soil conditions due to intensive tillage, minimal crop residues, heavy 

field traffic and long periods of bare soil (Hopkins 2010 p. 34). In the Northwest, potato fields are 

typically tilled both before and after the season (Hopkins et al. 2004 p. 9). Common practice in the Red 

River Valley is to plow once in the fall, till two or more times during the winter, and disc the field in the 

spring, just before planting (USDA 2000 p. 1). In the San Luis Valley, minimum and conventional tillage 

practices are both used (McDonald et al. 2003 p. 2).

Cover Crops

Cover crops may be used with soil high in clay to help keep them productive (Rosen 2010a p. 32). Some 

growers use a fall cover crop to help prevent erosion (Sexton 2010a p 36). Planting a cover crop such as 

winter rye or leaving cover crop residues near the surface can provide good control of wind erosion in 

sandy soils (Rosen 2010a p. 32). Incorporation of green manure crops that are tilled into the soil prior to 

planting has been effective in reducing disease pressure and erosion (Hopkins et al. 2004 pp. 5 and 9). 

Growers in Florida use Sudan grass as a cover crop which is turned into the soil to provide nitrogen prior 

to potato planting (Mossler and Hutchison 2011 p. 5).

Crop Rotation

Potato growers experience short-term economic pressure to continuous-crop potatoes, in part because 

they invest heavily in specialized equipment for potatoes and because potatoes typically represent the 

highest potential gross return per acre (Hopkins et al. 2004 p. 11). However, continuous cropping and 

short rotations of potatoes with other crops increases insect, disease, and nematode pressure, 

decreases soil nutrient levels, and increases erosion potential (Hopkins et al. 2004, pp. 5- 9; Delahaut 

2000 p. 29; Hall et al. 2000 pp. 8 and 10; Bennett and O’Rourke 2002 pp. 3 and 16). University of Idaho 

research has shown a 40 CWT per acre loss in yield for each year less than four between potato crops 

(Hopkins et al. 2004 p. 10). The main crops grown in rotation with potato in Idaho are small grains, 

sugar beets, alfalfa, dry beans and corn (Hopkins et al. 2004, p. 5). These crops are highly unlikely to 

facilitate intermingling with harvested potato tubers. Grains are commonly rotated with potatoes in the 

Red River Valley (USDA 2000 p. 1). In the San Luis Valley two-year rotations of potatoes and malting 

barley are predominant (McDonald et al. 2003, p. 2). Rotation crops in Wisconsin include corn, small 

grains, legumes and green manure (Delahaut 2000 p. 29). Rotations of 3 to 5 years are recommended in 

Minnesota and Wisconsin (Bennett and O’Rourke 2002 p. 16; Delahaut 2000 p. 20). Growers in certain 

areas of Florida (ex. Hastings and Parrish areas) typically plant potatoes year after year without crop 

rotation (David Parish, personal communication).
Environmental Report Page 13

Insect Control

Insects damage crops directly and can also transmit pathogens such as viruses. While specific problem 

insects vary among production regions, all regions practice insect control, usually with insecticides, 

which is necessary to prevent unacceptable losses of quality or yield (Radcliffe 2010 p. 64). The green 

peach aphid, Colorado potato beetle, and wireworms are the most serious insect pests in the Northwest 

(Bechinski et al. 2001 p. 2).

Disease Control

The process of vegetative propagation results in unique disease control problems for potatoes. A 

disease present in the seed potato cutting is typically transmitted to the resulting potato plant. In 

addition, the cut surfaces of the seed potatoes, until they are suberized, are open wounds that provide a 

route of entry for pathogens (Davidson 2010 p. 38). Of the many diseases in potato (Table 5), some are 

more common in production, while others become issues while tubers are in storage (Bechinski et al.

2001 p. 6). Control measures include use of fungicides, resistant cultivars, certified seed, crop rotation 

and other agricultural practices (Johnson et al. 2010 pp. 68-72).
Environmental Report Page 14

Table 5. Common Potato Disease and Insect Symptoms1

Insect or Disease Agent Symptom

Emposasca fabae (Potato Leafhopper) Leaf feeding damage

Epitrix species (Flea Beetle) Shot-holes in leaves

Leptinotarsa decemlineata (Colorado Potato 

Beetle)

Defoliation

Limonius californicus (Wireworm) Bored holes in tubers and shoots

Ostrinia nubilalis (European Corn Borer) Severe vine wilting above point of injury

Bactericera (Paratrioza) cockerelli (Potato Psyllid) Yellows

Phthorimaea operculella (Tuberworm) Foliar and tuber damage

Various aphid spp. Leaf suckling damage

Aster Yellows MLO Purple top disease

Potato Leafroll Virus Rolling of leaves and net necrosis

Potato Spindle Tuber Viroid Potato spindle tuber disease

Potato Virus A,M, X, Y Mosaic symptoms

Tobacco Rattle Virus Stem mottling

Erwinia carotovora Blackleg, aerial stem rot and tuber soft rot

Corynebactium sepedonicum Bacterial ring rot

Ralstonia solanacearum Brown rot

Phytophthora infestans Late blight

Phytophthora erythroseptica Pink rot

Verticillium spp. Early dying

Sclerotinia sclerotiorum Sclerotinia stalk rot

Rhizoctonia solani Canker

Streptomyces scabies Scab

Fusarium spp. Dry rot

Pythium ultimum Water rot, shell rot, Pythium leak

Alternaria solani Early blight

Botrytis cinerea Gray mold

1

This table is meant to give the reader a list of insects and diseases that may impact potatoes.

Weed Management

Weeds, which can cause substantial yield losses in potatoes due to competition for nutrients, water, and 

sunlight, are managed primarily through a combination of tillage and herbicides (Bechinski et al. 2001 

pp. 11-12; Delahaut 2000 p. 3; USDA 2000 pp. 16-17; Hutchison 2010, p. 63), although tillage can 

damage plants and reduce yields (Bechinski et al. 2001 p. 12). The majority of growers also scout their 

fields for indication of herbicide need, adjust herbicide use based on weed pressure, rotate chemical 

classes to avoid the development of resistant weeds, and choose rotational crops that compete 

successfully with weeds (Bechinski et al. 2001 p. 13). Examples of commonly used herbicides are 

metribuzin, EPTC, and metolochlor (Bechinski et al. 2001 p. 12, USDA 2000 p. 17; McDonald et el 2003 

pp. 16-17).

Volunteer Potatoes

Tubers left in fields after harvest may sprout and grow amidst a subsequent crop, competing with the 

rotational crop for sunlight, water, and nutrients. Volunteer potatoes can also be hosts for disease 
Environmental Report Page 15

(Boydston and Williams 2005 p. 443; Eberlein et al. 1998). Potatoes in moist soil will generally freeze 

and die at a soil temperature of 28 degrees Fahrenheit; in dry soil, soil temperatures must reach 25 

degrees Fahrenheit before the potatoes freeze (Eberlein et al. 1998). For the most temperaturetolerant varieties, exposure to temperatures less than 26 degrees Fahrenheit for more than 72 hours is 

required to kill the tuber (Everman et al. 2010). Several herbicides are used for the control of volunteer 

potato plants (Boydston and Williams 2005 p. 443; Everman et al. 2010). Post-harvest grazing and 

rotation to competitive crops can also help reduce volunteers (Eberlein et al. 1998). In most cases these 

plants will be eliminated by normal agronomic practices (OECD 1997 p. 23). 

Outside the field, potato seedlings will have difficulty establishing themselves, as they cannot compete 

with other plants. Potato tubers can be spread during transportation and use, but generally these plants 

cannot establish themselves for a long period of time due to unfavorable environmental conditions. In 

general, potato is not known as a colonizer of unmanaged ecosystems. In climax vegetation it is not able 

to compete with other species such as grasses, trees and shrubs (OECD 1997 p. 23).

Organic Production Practices

The National Organic Program

In the U.S., only products produced using specific methods and certified under the USDA National 

Organic Program (NOP) program definition of organic farming can be marketed and labeled as “organic” 

(7 CFR §205.102). The NOP requires organic growers to have distinct, defined boundaries and buffer 

zones to prevent unintended contact with prohibited substances or products of excluded methods from 

adjoining land that is not under an organic production management plan (7 CFR 205.202(c)). Organic 

production operations must also develop and maintain an organic production system plan approved by 

an accredited certifying agent. This plan enables the grower to achieve and document compliance with 

the National Organic Standards, including the prohibition of the use of excluded methods (7 CFR Part 

205), which include a variety of methods used to genetically engineer organisms or influence their 

growth and development by means that are not possible under natural conditions or processes. The use 

of biotechnology such as the InnateTM method is an excluded method under the National Organic 

Program (7 CFR § 205.2).

Organic producers must use organically grown seed if it is available (7 CFR §205.204). Several 

companies produce organically grown seed (e.g., High Mowing Seed Company, Abundant Life Seed 

Company; Dufour et al. 2009 p. 3). 

Organic Potato Production

In the U.S. in 2008, the most recent year for which data is available, a total of 7,989 acres of organic 

potatoes were harvested on 1,331 farms (averaging 6 acres per farm). USDA NASS reported organic 

potato production for 45 states (2010 Table 4), and the organic harvested acres represent only 0.7 

percent of the total U.S. 2008 harvested potato acreage of 1,059,600 (USDA NASS 2010 p. 8). USDA 

NASS reported harvested acreage in 2008 (in parenthesis) for states with more than 250 harvested acres 

as follows: California (1,977), Colorado (1,921), Washington (1,477), Oregon (840), and Idaho (736) 

(USDA NASS 2010 Table 4). 

Some organic potatoes are grown in the same area where potatoes are produced using conventional 

methods. The majority of California’s organic potato production occurs in three interior agricultural 

valleys: San Joaquin, Antelope and Cuyama, as well as in the Klamath basin on the Oregon border. In 
Environmental Report Page 16

the Klamath Basin, nearly all the organic potatoes are produced for the fresh market, with a very small 

percentage (1 percent in 2006) for chips (Miller et al. 2008 p. 13). All organic potatoes grown in 

California are for the fresh market, and most are shipped to the East Coast (Miller et al. 2008 p. 11). 

Organic potatoes in Colorado are grown in the San Luis Valley and in Weld County northeast of Boulder. 

Nearly all production in Colorado is for fresh market consumption (Miller et al. 2008 p. 12). In the 

Columbia Basin (Washington and Oregon), potatoes are grown for both processing and fresh use. Some 

farms produce both organic and conventional potatoes (Miller et al. 2008 p. 12). In Idaho, organic 

potato production occurs primarily in the Snake River Valley, and supplies both fresh and processing 

markets. 

Organic growers utilize many of the same production methods used by conventional growers for 

planting and harvesting, as well as for managing insects, weeds, and disease. However, organic growers 

do not use synthetic fertilizers or pesticides (Miller et al. 2008 pp. 12-37; Seaman 2011 pp. 2-52) but 

rather control weeds largely by tillage (Dufour et al. 2009 p. 9). Organic potato growers may use longer 

crop rotations, compost, compost tea and biological control for pests. Thus, organic farm plots are likely 

to be smaller in scale (Miller et al. 2008 pp. 12-37; Dufour et al. 2009 Table 1 and pp. 9-19). 

2.3. Physical Environment

Water Resources

The majority of the potatoes produced in the U.S. are grown under irrigation, including potatoes grown 

in the Snake River Plain, the Columbia Basin, the San Luis Valley, and the Central Sands region of 

Wisconsin (Bechinski et al. 2001, Washington State Potato Commission 2011, Delahaut 2000, McDonald 

et al. 2003, Oregon State University 2008). Approximately one-quarter of potatoes grown in North 

Dakota are produced with irrigation (USDA 2000). Rainfall provides most of the moisture for potato 

crops in Maine; however, supplemental irrigation has been shown to result in increased yields (Sexton et 

al. 2008). 

Agricultural production, including potatoes, can adversely impact surface water quality, primarily 

through sedimentation from erosion and nutrient loading from fertilizers (US EPA 2005; US EPA 2009 pp. 

11 and 12). 

Crop production has the potential to impact groundwater in areas with shallow (less than approximately 

15 feet deep) water tables through leaching of the nitrates from fertilizers (Nolan et al. 2002, p. 2138).
Environmental Report Page 17

Soil Quality 

Ideal soil for potato growing is deep, soft, and well-drained; however, potatoes can be grown on a wide 

variety of soil types and pH values. Soil type is less important under irrigation (which is how most 

potatoes in the U.S. are grown) because water can be applied as needed. Cover crops, timely tillage, 

and appropriate crop rotation are important for soils high in clay. Soils high in organic matter such as 

peat or muck, when adequately drained, can also produce high quality potatoes, particularly for the 

fresh market. Sandy soils can also produce high-quality potatoes, but wind erosion can pose a problem 

(Rosen 2010a, p. 32). 

The relatively high tillage requirements of a potato crop, coupled with the small amount of post-crop 

plant material, can contribute to higher erosion potential. Growing a cover crop and utilizing the 

subsequent crop plant material can provide protection against erosion (Rosen 2010a, p. 32; Hopkins 

2010 p. 34). Potential for soil erosion is related to cultural practices and soil types and not to the 

specific varieties grown.

Air Quality

Air emissions associated with crop agriculture include vehicle emissions, fugitive dust (from disturbance 

of bare soil from wind or farming activities), and emissions associated with applications such as fertilizer 

and pesticides. In some areas, prescribed burning is practiced and results in higher emissions levels (US 

EPA 2011b, p. 3). 

The Clean Air Act (CAA) requires the US EPA to identify pollutants that may endanger public health or 

welfare. Under the CAA, the US EPA establishes standards for each pollutant for which air quality criteria 

have been issued (National Ambient Air Quality Standards). These pollutants currently include ozone, 

carbon monoxide, particulate matter, nitrogen dioxide, sulfur dioxide, and lead (40 CFR Part 50). Each 

state is required to develop and implement plans (State Implementation Plans) to demonstrate how the 

standards will be met within the state. Areas with air pollution concentrations that exceed one or more 

of the standards that the US EPA has set for these pollutants are referred to as non-attainment areas. 

Non-attainment areas are typically associated with large metropolitan areas with many mobile (e.g., 

vehicle) and stationary (e.g., power plants and factories) sources. Other than emissions from mobile 

sources, crop farming emission sources are not specifically regulated nationwide under the CAA. The 

degree to which emissions from farming practices (such as prescribed burning) are allowed are locationspecific within each State Implementation Plan (US EPA 2011b, p. 3). Regulation of agricultural sources 

within a State Implementation Plan does not appear to be typical. For example, based on a review of 

the available plans in Idaho, achievement of air quality standards is focused on managing residential 

wood burning, vehicle emissions, and facilities such as factories and processing plants (US EPA 2011c, 

pp. 1-9). 

US EPA regulates emissions from mobile sources through such mechanisms as reformulated gasoline 

and automobile pollution control devices (US EPA 2011b). Stricter requirements, such as vapor recovery 

nozzles on gas pumps, may apply in non-attainment areas. 

Climate Change 

Greenhouse Gas Emissions from Agriculture
Environmental Report Page 18

Each year the US EPA prepares an inventory of greenhouse gas emissions for the U.S. (US EPA 2012, p. 

iii). Greenhouse gases vary in their global warming potential (GWP), and the US EPA converts all gases 

to carbon dioxide (CO2) equivalents. For the three greenhouse gases most associated with agriculture, 

GWPs are as follows: CO2 = 1, methane (CH4) = 21, and nitrous oxide (N2O) = 310 (US EPA 2012, p. ES3). The US EPA classifies different sources by sector, with the energy sector being the largest 

contributor of greenhouse gas emissions (US EPA 2012 pp. ES-11 and ES-12). The agriculture sector, as 

defined by US EPA, represented 6.3 percent of total greenhouse gas emissions for the U.S. in 2010 (US 

EPA 2012 p. ES-13). However, this does not include CO2 emissions and removals from agriculturalrelated land use activities such as liming of agricultural soils (which are included in the land use sector) 

and it does not include emissions of CO2 and NO2 from diesel or gasoline-powered agricultural 

equipment (which are included in the energy sector). The primary greenhouse gases contributed by the 

agriculture sector as defined by US EPA are N2O and CH4. The relative percent contribution to total CO2 

equivalent emissions of the various agricultural sources in 2010 was as follows: agricultural soil 

management (fertilizer application and other cropping practices that contribute N2O), 49 percent; 

enteric fermentation (primarily methane emissions from cattle), 33 percent; manure management, 16 

percent; and rice cultivation, two percent. Emissions from field burning of agricultural residues, the 

remaining category, were less than 0.1 percent of the total (US EPA 2012, p. 6-1). 

2.4. Biological Resources

Animal Communities 

Potatoes are grown throughout the U.S., and therefore there is a wide range of animal communities that 

might be found in potato fields and surrounding areas. This discussion focuses on the types of animal 

communities that may be affected by potato farming. 

Animals within Agricultural Fields

Animals generally need food, shelter, and open bodies of water for survival. Of these primary needs, 

cropland may provide food and/or shelter for some animals; however, in a potato field the animals 

seeking to consume the potato plant or tubers are in direct competition with the grower whose 

livelihood depends on harvesting as large a yield as possible from his fields. Many animals, including 

birds and some invertebrates, are not detrimental to yields and may be beneficial to the grower by 

providing pest control.

 

Animals Outside of Agricultural Fields

Animals living outside but near agricultural fields may be impacted by introduced materials from the 

fields. These releases could include pesticides (which are regulated by US EPA) into air and water, and 

soil particles, which may be released into air or water. Animal communities most likely to be impacted 

while living near agricultural fields are aquatic species affected by sedimentation and turbidity resulting 

from erosion. 

Plant Communities, Gene Flow, and Weediness 

In general, all plants growing within an agricultural crop field that are not the intended species are 

weeds, and need to be controlled in order to reduce competition with crops for survival. Weed 
Environmental Report Page 19

management is discussed in Section 2.2, Agricultural Production of Potatoes: General Agronomic 

Practices.

The landscape surrounding a potato field may be bordered by other potato fields, other crops, or may 

be surrounded by forest, grassland, bodies of water, or built-up areas. As discussed in Section 2.2, most 

commercial potatoes are grown in large agricultural areas, such as the Snake River Valley in Idaho. Thus, 

other crops would most frequently make up the surrounding vegetation, although some fields would be 

bordered by non-crop vegetation. Growers may provide buffer zones to reduce or prevent impact to 

adjacent vegetation. Because potatoes are grown throughout much of the U.S., a wide variety of plants 

may be found adjacent to the agricultural fields. These plants have the potential to be impacted by 

agricultural practices, including the use of pesticides, which are regulated by US EPA. Aquatic plant 

communities near agricultural fields may be affected by sedimentation resulting from erosion, or by 

nutrients leached from fertilizers. 

Native or wild plant species related to cultivated potatoes are of interest because of the potential for 

interbreeding through gene flow. By definition, interbreeding between species that result in viable 

offspring is not common, otherwise the two plants would not be classified as different species. 

Interbreeding can occur to a limited extent between some species under some circumstances. Among 

the many factors that must be present for hybridization to occur between two species are these: 1) the 

species must occur in the same area and habitat, 2) the flowering periods of the species involved must 

overlap, and 3) appropriate pollinating factors must be present (OECD 1997 p. 21). 

This section summarizes the Solanaceae family, and then discusses in detail the two wild potato species 

that are found in the southwestern U.S. It ends with an assessment of the potential for gene flow 

between native and cultivated potatoes in the U.S.

Potato Characteristics

Hybridization via pollen transfer is not possible with the Russet Burbank, the most commonly grown 

potato, as it is infertile (NSF 2011, PAA 2009a, Collinge and Clark 2013). Hybridization via pollen transfer 

is also not possible with the “H” variety as it is infertile (Collinge and Clark 2013). Of the fertile varieties 

(including Ranger Russet, Atlantic and “G”), approximately 80 to 100 percent of true seed produced is 

derived from self-pollination (Plaisted 1980 p. 491).

Cross-pollination in potatoes is typically mediated by certain insects including bumblebees (Bombus 

impatiens) that do not travel much more than 2 miles (OECD 1997 p. 17). Other bee species such as 

honey bees (Apis mellifera) are not pollinators of potatoes since potato flowers do not contain ample 

nectar (OECD 1997 p. 17). Pollination by wind is apparently insignificant (OECD 1997 p. 17). Field 

evaluations in New Zealand, the United Kingdom, and Sweden demonstrated through genetic testing 

that outcrossing was not detected when the receiving potato plants were separated by a minimum of 20 

meters (65.6 feet) from genetically modified potato plants (Connor and Dale 1996 p. 505-506). 

Solanaceae Family

The Solanaceae family contains several well-known cultivated crops such as tomato (Solanum 

lycopersicum also referred to as Lycopersicon esculentum), eggplant (Solanum melogena), tobacco 

(Nicotiana tabacum), pepper (Capsicum annuum), and potato (Solanum tuberosum) (OECD 1997 p. 12). 

Within the genus Solanum, over a thousand species have been recognized. The genus Solanum is divided 
Environmental Report Page 20

into several subsections, of which the subsection potatoe contains all tuber-bearing potatoes. The 

subsection potatoe is divided into series, of which tuberosa is relevant to this document. Within the 

series tuberosa approximately 54 species of wild and cultivated potatoes are known, with one of these 

being S. tuberosum. (OECD 1997, p. 12). 

S. tuberosum is divided into two subspecies: tuberosum and andigena. The subspecies tuberosum is the 

cultivated potato widely in use as a crop plant in North America and Europe. The subspecies andigena is 

also a cultivated species, but cultivation is restricted to Central and South America (OECD 1997, p. 12). 

Wild Potatoes in the U.S.

This discussion is based on data in the U.S. Potato Genebank and on a monogram published by the 

American Society of Plant Taxonomists entitled Wild Potatoes (Solanum section Petota; Solanaceae) of 

North and Central America (Spooner et al. 2004). The USDA maintains the US Potato Genebank and 

participates in the Association of Potato Inter-genebank Collaborators (APIC), which has produced a 

global inventory of wild potato genetic resources available on the internet, the Inter-genebank Potato 

Database (IPD), which includes the U.S. Potato Genebank records. Many of the IPD records from the 

U.S. were obtained by John Bamberg and associates (including Spooner) during a decade of collecting 

wild potatoes in the Southwest U.S. (Bamberg et al. 2003)3 

The only two wild potato species that grow within the borders of the USA and for which specimens exist 

in genebanks include the tetraploid species. S. fendleri (recently reclassified as S. stoloniferum; however, 

some sources including the IPD still use the S. fendleri designation) and the diploid species S. jamesii 

(Bamberg et al. 2003; IPD 2011; Bamberg and del Rio 2011a, p. 1444; Bamberg and del Rio 2011b; and 

Spooner et al. 2004 pp. 33 and 88).4Through more than 10 years of field work and assessments of 

existing records, Bamberg et al. (2003) and Spooner et al. (2004) established the presence of only these 

two species in the U.S. These researchers also attempted to verify previously recorded locations and 

through this process, updated the maps of current known locations of these species, providing latitude 

and longitude locations for each documented population (Bamberg et al. 2003, Figure 2). 

 

3

By comparison to the IPD and Spooner et al. 2004, the USDA Plant Database is much more general; is 

based mostly on literature sources, some of which are more than 50 years old; and has not yet been 

updated with the more recent information obtained by researchers.

4

Three other species were previously recorded as being present in the U.S.(see discussion in Bamberg et 

al. 2003, pp. 160-161). The USDA Plant Database still includes the other three species. 
Environmental Report Page 21

Figure 2. Potato Production in the United States. 

County Information is for states with wild potato populations ( Hijmans and Spooner, 2001)

There are approximately 160 records in the IPD for the U.S.; approximately half of the wild species are S. 

fendleri and the other half are S. jamesii (IPD 2011). Ninety percent of these records are from New 

Mexico and Arizona and the rest are from Colorado, Utah, and Texas (IPD 2011). All of the records for S. 

fendleri are from New Mexico and Arizona, except two found in western Texas (IPD 2011). Spooner et 

al. report that the northernmost extent of wild potatoes (S. jamesii only) is 38 degrees north latitude 

(2004, pp. 1 and 2), which is one degree north of the southern border of Utah and Colorado, which lies 

at 37 degrees north latitude. The northernmost extent of S. fendleri (S. stoloniferum) is approximately 

35 degrees north latitude (Spooner et al. 2004, Figure 35).

Bamberg et al. noted that “during their collection expeditions, flowering and fruiting were not 

commonly observed, and most of the plants appeared to be tuberlings, suggesting that reproduction is 

usually clonal” (Bamberg et al. 2003, p. 167). However, later Bamberg and del Rio reported that S. 

fendleri “produce abundant seed from selfing and have been shown by DNA markers to be very 

homogenous within populations” (Bamberg and del Rio 2011a p. 1444). 

Often the researchers were searching for previous collection sites, which were apparently very difficult 

to find. Spooner et al. reported: “Wild potatoes can be very difficult to locate, and two or more days of 

intensive searches, in areas where potatoes are documented to occur, often pass without locating them 

(2004, p. 26). As Bamberg et al. noted, the wild potatoes “may exist as single colonies in vast areas” 
Environmental Report Page 22

(2003 p. 166), and are found in mountainous regions at elevations over 1,500 meters (approximately 

5,000 feet) (Bamberg et al. 2010, Del Rio et al. 2001, Bamberg et al. 2003).

All Texas records in the IPD database are from the far western part of the state in El Paso, Culbertson, 

and Jeff Davis Counties, where potatoes are not grown commercially. The two S. fendleri and one of the 

S. jamesii records are from the Davis Mountains and one of the three S. jamesii entries is from 

Guadalupe National Park (IPD 2011 p. 5; National Atlas 2004d; USDA NASS 2012; Hall et al. 2000 p. 1). 

Based on mapped locations, the current S. fendleri records for Arizona are all from the southeastern part 

of the state, while the S. jamesii records are primarily from the northeastern half of the state (when 

divided diagonally) (Bamberg et al. 2003, p. 165; IPD 2011). USDA reports recent county level data for 

potato production only for Maricopa County, Arizona, which is in the southwestern part of the state; 

other potato production does exist but is not large enough in scale to be reported at the county level 

(USDA NASS 2012). USDA reports potato production data for 2007 by county for New Mexico. Only one 

county had more than 12 acres of harvested potatoes, McKinley County in northwestern New Mexico. 

All mapped S. fendleri records are in the southern part of the state; the single site that is not in the south 

is over 100 miles from McKinley County (Bamberg et al. 2003, p. 165; Spooner et al. 2004, Figure 35). S 

jamesii sites are scattered through most parts of the state (Spooner et al. 2004, Figure 7).

The Colorado records in the IPD database are from mountainous locations very near the New Mexico 

border. Spooner et al. reported that “records of S. jamesii from natural habitats in in Colorado are 

limited to the extreme southwestern and southeastern parts of the state” (2004 p. 36). The San Luis 

Valley, a major potato production area, lies between the mountainous regions where the wild potatoes 

were found (USDA NASS 2012, Bamberg et al. 2003 p. 165, National Atlas 2004c; Spooner et al. 2004, 

Figure 7). 

While there appears to be minimal, if any, overlap geographically between cultivated and wild potatoes 

in the U.S., there is a possibility that a few wild potato plants may be growing near potato fields (Love 

1994 p. 652). Spooner et al. describe S. jamesii habitat in the U.S. as follows: “Among boulders on 

hillsides, sandy alluvial stream bottoms, in gravel along trails or roadways, rich organic soil of alluvial 

valleys, sandy fallow fields, grasslands, juniper-pinyon scrub deserts, oak thicket, coniferous and 

deciduous forests” at elevations between 1370 and 2870 meters (4,500 to 9,400 feet). They describe S. 

stoloniferum (S. fendleri) habitat similarly: “Among boulders on steep hillsides, sandy alluvial stream 

bottoms, in gravel along trails or roadways, in thick leaf mulch under trees, at edges of cultivated or 

fallow fields, along fencerows and railways, in organic moist soil to dry sandy soils, in grasslands, juniperpinion scrub, desert tropical deciduous forests, and pine, fir, juniper and oak forests” at elevations 

between 1440 and 3400 meters (4,700 to 11,200 feet).

Hybridization Potential

Based on conversations with Bamberg, Love (1994) reported that no one has ever reported finding 

hybrids between native and cultivated potatoes in the U.S., although gene transfer has been 

accomplished using special laboratory techniques (Love 1994 p. 653). Love concluded that, based on the 

barriers that exist, including geographic isolation (as described above), endosperm imbalances, and 

multiple ploidy levels, natural hybridization is “highly unlikely” and introgression (cross hybridization 

over multiple generations) is “impossible or at least highly improbable” (Love 1994 p. 647) without 

human intervention. More recently, US EPA has concluded that, based on its review of the scientific 

literature, successful gene introgression between native and cultivated potatoes in the U.S. “is virtually 

excluded due to constraints of geographical isolation and other barriers to natural hybridization”. These 

barriers include incompatible (unequal) endosperm balance numbers that lead to endosperm failure and 
Environmental Report Page 23

embryo abortion, multiple ploidy levels, and incompatible mechanisms that do not express reciprocal 

genes to allow fertilization to proceed. No natural hybrids have been observed between these species 

and cultivated potatoes in the U.S. (US EPA 2011d, pp. 9 and 10). 

Threatened and Endangered Species

There are currently three plants in the genus Solanum on the U.S. Fish and Wildlife Service (US FWS) list 

of threatened or endangered plant species: Erubia (S. drymophilum), found only in Puerto Rico; and 

popolo ku mai (S. incompletum) and Aiakeakua popolo (S. sandwicense), both found only in Hawaii (US 

FWS 2011, p. 47). Based on the evaluation of wild potatoes presented above, these species would not 

interbreed with cultivated potatoes; additionally, potatoes are not commercially grown in these areas. 

Microorganisms 

Land used for growing crops supports a rich and complex community of below ground microorganisms. 

The interactions among the below ground community, plant root structure, and organic residues in the 

soil are critical for maintenance of a variety of dynamic soil ecological processes, including the 

decomposition of organic material, nutrient cycling, and release, and maintenance of soil structure and 

composition. Growth of desirable microorganisms is facilitated by the presence of organic material and 

appropriate soil pH (Rosen 2010b, p. 36, Sexton 2010b, p. 37).

Pathogenic microorganisms, primarily associated with disease, are discussed in Section 2.2, Agricultural 

Production of Potatoes: General Agronomic Practices. 
Environmental Report Page 24

Biodiversity 

General Biodiversity

Biodiversity refers to all species of plants, animals, and microorganisms existing and interacting within 

an ecosystem (Altieri 1999 p. 19). By intent, modern agricultural ecosystems have low plant diversity 

compared to the native systems they have replaced; on any given field, it is the grower’s goal to 

cultivate one plant to the exclusion of others. While traditional cropping systems have higher plant 

diversity than modern systems (Altieri 1999 p. 20), they usually have lower productivity. For example, as 

discussed in Section 2.1, per-acre potato yields have increased 8-fold since the 1900s when traditional 

cropping systems were used. While the in-field biodiversity of modern farming has declined, the 

increases in productivity have supported a growing population without the need to expand area 

devoted to farming, thus allowing the preservation of biodiversity on other lands. In 2006, the most 

recent year for which data is available, the total agricultural land used for crops in the U.S. was 330 

million acres - the same as it was in 1910, the first year USDA began tracking - while at the same time 

the U.S. population increased from 92 million to 298 million (USDA ERS 2007, US Census Bureau 2010, 

US Census Bureau 2011). 

Because potatoes are grown across the country (from Florida to Alaska) there is a large diversity of 

plants and animals that inhabit the areas surrounding the potato fields. 

Potato Biodiversity

There is substantial genetic diversity among wild potato species, and this diversity can be used to 

improve cultivated potatoes. Approximately 200 species of wild potatoes have been identified, and all 

of them are in the Americas (Hijmans and Spooner 2001 p. 2103, FAO 2008 p. 14). The greatest 

biodiversity among the species of wild potato is found in the Andes; a total of 196 species have been 

identified in Peru, Bolivia, Mexico, and Argentina, with 93 in Peru alone (Hijmans and Spooner 2001 p. 

2103). These wild species “represent a veritable treasure chest of genetic diversity for potentially useful 

traits that may someday be bred into new varieties” (USDA ARS 2011). 

2.5. Human Health

Consumer Health 

The potato is the world’s number one non-grain food commodity (FAO 2008 p. 3). Potatoes are rich in 

carbohydrates, making them a good source of energy. They have the highest protein content (around 

2.1 percent on a fresh weight basis) in the family of root and tuber crops, and protein of a fairly high 

quality, with an amino-acid pattern that is well matched to human requirements. They are also very rich 

in vitamin C (a single, medium-sized potato contains about half the recommended daily intake) and 

contain one-fifth of the recommended daily value of potassium (FAO 2008 p. 4).

U.S. per capita potato consumption is summarized in Table 6 (NPC 2012). 
Environmental Report Page 25

Table 6. U.S. Per Capita Potato Consumption 2012 (Pounds)

Fresh 

Market

Processing All 

Canned Frozen Chips Dehydrated Potatoes Total 

Processing

35 1 50 15 12 78 112

1NPC 2012; totals may not add due to rounding.

Toxins and Allergens in Potato

Acrylamide forms in foods primarily during the Maillard Reaction, a reaction at high temperatures (such 

as frying french fries) between certain sugars such as glucose and fructose (reducing sugars) and 

asparagine (an amino acid) that are naturally present in the food (US FDA 2009 p. 2). 

Glycoalkaloids are well-known naturally-occurring toxicants that are present in all potatoes. For food 

safety purposes, an upper limit for glycoalkaloid content of 20 milligrams per 100 grams of potato is 

generally accepted (Sinden 1987 p. 41). 

Patatin is a type of protein that makes up about 40 percent of the soluble protein in potatoes (Mignery 

et al. 1988 p. 27). Allergic reactions to potatoes are considered to be very uncommon and have been 

reported for children only (De Swert et al. 2007 p. 750), with patatin identified as the major allergen 

involved in this reaction (De Swert et al. 2007 p. 755). Because potato protein naturally contains a 

relatively large proportion of patatin, those who are allergic to patatin wound need to avoid eating 

potatoes.

Worker Safety 

Farm workers are exposed to a number of work place hazards, including those associated with farm 

equipment and pesticide use. The US EPA’s Worker Protection Standard (WPS; 40 CFR Part 170) 

requires actions to reduce the risk of pesticide poisonings and injuries among agricultural workers and 

pesticide handlers. The WPS contains requirements for pesticide safety training, notification of pesticide 

applications, use of personal protective equipment, restricted entry intervals following pesticide 

application, decontamination supplies and emergency medical assistance.

2.6. Livestock Health Considerations

Animal Feed (Livestock Health)

USDA reports that only a small part of the potato crop (593,000 CWT (29,560 tons) in 2010) was used for 

livestock feed (see Table 7). This tends to include only potatoes that are sold specifically as livestock 

feed, and not the potato waste that is used for livestock feed; Simplot uses both raw and processed 

potato waste products as livestock feed on its company-owned feedlots in the Northwest. The potato 

waste consists of peels and potato material that does not meet certain specifications. At Simplot’s 

Grandview, Idaho feedlot alone, approximately 15,000 tons of processed potato waste and 60,000 tons 

of raw potato waste are integrated into livestock feed annually. The typical feed ration used for cattle 
Environmental Report Page 26

finishing includes approximately 5 to 8 percent raw potato waste and 3 to 6 percent processed potato 

waste (Collinge and Clark 2013). 

Potato foliage is not provided as feed to livestock. Flowers, sprouts and foliage are particularly rich in 

glycoalkaloids, and it is recognized that these parts of the potato plant are potentially poisonous for 

livestock (Sinden 1987, p. 41).

2.7. Socioeconomic Considerations

Domestic Economic Environment 

The total value of U.S. potato production in 2009 was $3.5 billion, the average yield was 414 CWT/acre 

and the average price received was $8.25/CWT (USDA NASS 2011, p. 16). 

Unlike true commodity crops such as corn and soybeans, most potatoes are grown for a particular 

market. As shown in Table 2, the Russet Burbank and Ranger Russet are used for fries and the Atlantic, 

“H”, and “G” varieties are used for chips. Atlantic is the standard for making potato chips from the field 

or from very short storage (PAA 2009b). Any of these can also be sold on the fresh market. On the fresh 

market, Russet Burbank potatoes are the standard for baking (PAA 2009a), and Ranger Russet potatoes 

are also well-suited for baking (Pavek et al. 1992 p. 483). Other varieties are used for canning and are 

well-suited for boiling. There are thousands of potato varieties, some intended for very small markets, 

one example being the Vitelotte, which has blue skin and purple flesh (Food and Agriculture 

Organization of the United Nations (FAO) 2008 p. 21).

U.S. 2010 potato utilization is summarized in Table 7. Specific varieties are not grown for the 

dehydration market or for livestock feed, rather, food-grade potatoes considered unsuitable for their 

intended fresh or other processing markets are usually used for dehydration and feed (Guenthner 

2010b, p. 17). Because potato sales for livestock feed usually receive the lowest price, potatoes are not 

sold for livestock feed if other uses are available (Guenthner 2010d, p. 16). 
Environmental Report Page 27

Table 7. U.S. 2010 Potato Utilization.

Utilization Item CWT (1,000)

Sales – fresh and processing 

Table stock (fresh) 107,407

Processing

 Chips and shoestrings 54,692

 Dehydrated (except starch and flour) 34,130

 Frozen french fries 135,557

 Other frozen products 13,360

 Canned products 1,658

 Other canned products (hash, stews, soup) 689

 Starch, flour and other 6,356

 Total processing 246,442

Other sales

Livestock feed 593

Seed 20,621

Non-sale

Seed used on farms where grown 3,002

Household and feed use on farms where grown 1,218

Shrinkage and loss 24,990

Total Production 404,273

Source: USDA NASS 2011

Revenues and costs of potato production vary widely, depending on geography, growing conditions, the 

local economy, the type of potato, and other factors. For example, the 2011 per acre operating cost of 

growing Russet Burbank potatoes in Southwestern Idaho, including on-farm storage and fumigation, was 

$2,811 (Patterson 2011, p. 29). In the same year, the gross return per acre averaged $4,107.50, 

resulting in a net return of $1,297. When that same variety was grown in South-central Idaho, the 2011 

per acre operating cost, including on-farm storage and fumigation, was $2,560 (Patterson 2011, p. 35), 

and the gross return per acre averaged $3681.25, resulting in a net return of $1,121. The largest 

operating cost items are fertilizer, chemicals and pesticides, storage and seed potatoes (Patterson 2011, 

p. 29). Sales value per acre is normally highest for the winter crop and lowest for fall potatoes, but varies 

widely among the producing states. Prices for fresh potatoes are usually higher than prices for 

processing potatoes due to crop-quality standards. Domestic potato prices may vary not only in 

response to changes in weather, yield or demand, but also to changes in supply from imported potatoes 

and potato products. If a large quantity of frozen french fries enters the country, U.S. potato processors 

may cut back on contracts for processing potatoes, which would be diverted to the fresh market. Fresh 

market prices would likely fall as a result (USDA ERS 2012a, p.3).

Most fresh market potatoes in North America can be classified as russets, reds, yellows or whites based 

on skin color. Most eastern potato growers are also involved in packing; in the west, the businesses are 
Environmental Report Page 28

usually separate. Recently, western growers have entered the packing business, often in partnerships or 

cooperatives with other growers (Guenthner 2010c, p. 18). Fresh potatoes may be shipped in 

refrigerated rail cars or trucks to maintain a high standard of quality. 

Typically, frozen and dehydration processing occurs near potato production areas whereas the chipping 

industry is more spread out. The fragility of chips and the high cost of shipping low-density products 

results in most chipping plants being located near populated areas. Except for dehydrators, processors 

typically contract for most of their needs and buy the remainder on the open market. Some 

dehydrators segregate potatoes that are suitable for the fresh market, and then sell those on the fresh 

market, processing the rest. Others purchase off-grade potatoes from fresh packers for processing 

(Guenthner 2010b, p. 17). 

Organic Potatoes

Organic potato production is discussed in Section 2.2, Agricultural Production of Potatoes: Organic 

Production Practices. A total of 2.3 million CWT of organic potatoes were harvested in 2007, with a total 

sales value of $30 million ($13.19/CWT) (USDA NASS 2010 Table 4). This price is substantially higher 

than the overall average potato price, and probably reflects both the organic premium and the fact that 

most organic potatoes are sold fresh. Organic growers generally receive a significant price premium 

when they can sell their potatoes as organic (Dufour et al. 2009 p. 27); however, that market is not 

always available (Esplin 2009 p. 1). The organic potato market is not highly structured (Dufour et al.

2009 p. 25). At least one manufacturer produces organic potato chips (Kettle Foods 2009).

Trade Economic Environment 

In 2011, U.S. exports of all potatoes and potato products totaled $1.5 billion—up from $1.3 billion in 

2010 (USDA ERS 2012b, p. 3). Demand from Canada, Mexico and Asia is driving growth in exports. For 

2011, the U.S. had a $388 million trade surplus with respect to all potato products, with the largest net 

imports from Canada. Japan is the largest market for U.S. exports of frozen potatoes while Canada is the 

largest US export market for chips and fresh potatoes. Frozen french fries account for more than half of 

the value of U.S. potato product exports (USDA ERS 2012c, p. 19).

3. Alternatives

This section analyzes the potential environmental consequences of a determination of nonregulated 

status of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50. To respond favorably to a petition 

for nonregulated status, APHIS must determine that events E12, E24, F10, F37, J3, J55, J78, G11, H37, 

and H50 are unlikely to be a plant pest risk. If based on its PPRA, APHIS concludes that events E12, E24, 

F10, F37, J3, J55, J78, G11, H37, and H50 are unlikely to pose a plant pest risk, APHIS must determine 

that events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are no longer subject to 7 CFR Part 340 or 

the plant pest provisions of the Plant Protection Act.

Two alternatives are evaluated in this ER: Alternative I as the no action alternative; and Alternative II as 

the determination of nonregulated status. APHIS will assess the potential for environmental impacts for 

each alternative in the Environmental Consequences section.

3.1. Alternative I: No Action
Environmental Report Page 29

Under Alternative I: No Action, APHIS would deny the petition. Events E12, E24, F10, F37, J3, J55, J78, 

G11, H37, and H50 addressed by this ER and progeny derived from them would continue to be regulated 

articles under the regulations specified in section 7 CFR Part 340. Permits issued or notifications 

acknowledged by APHIS would still be required for introductions of the potato events addressed in this 

ER and measures to ensure physical and reproductive confinement would continue to be implemented. 

APHIS might choose this alternative if there were insufficient evidence to demonstrate the lack of plant 

pest risk from the unconfined cultivation of potatoes derived from events E12, E24, F10, F37, J3, J55, 

J78, G11, H37, and H50 addressed in this ER.

3.2. Alternative II: Approval of Petition in Whole

Under this alternative, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 addressed in this ER 

would no longer be regulated articles under 7 CFR Part 340. Permits issued or notifications 

acknowledged by APHIS would no longer be required for the introduction and cultivation of these 

potatoes. This alternative meets the purpose and need to respond appropriately to a petition for 

nonregulated status based on the requirements in 7 CFR Part 340 and the agency’s authority under the 

plant pest provisions of the Plant Protection Act. When the agency has concluded that events E12, E24, 

F10, F37, J3, J55, J78, G11, H37, and H50 are unlikely to pose a plant pest risk, a determination of 

nonregulated status of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 will be a response that 

is consistent with the plant pest provisions of the Plant Protection Act, the regulations codified in 7 CFR 

Part 340, and the biotechnology regulatory policies of the Coordinated Framework.

Under this alternative, potato growers and processers may have future access to events E12, E24, F10, 

F37, J3, J55, J78, G11, H37, and H50 and progeny derived from these events if the developer decides to 

commercialize events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50.

3.3. Comparison of Alternatives

Table 8 presents a summary of the potential impacts associated with selection of either of the 

alternatives evaluated in this ER. The impact assessment is presented in Section 4 of this ER.

Table 8. Summary of potential impacts.

Attribute Alternative I: No Action Alternative II: Nonregulated

Agricultural Production Considerations

Land Use Unchanged Unchanged

General Agronomic Practices Unchanged Unchanged

Organic Production Practices Unchanged Unchanged

Environmental Considerations

Water Resources Unchanged Unchanged

Soil Quality Unchanged Unchanged

Air Quality Unchanged Unchanged

Climate Change Unchanged Unchanged

Animal Communities Unchanged Unchanged

Plant Communities, Gene Flow, 

and Weediness

Unchanged Unchanged

Microorganisms Unchanged Unchanged
Environmental Report Page 30

Biodiversity Unchanged Unchanged

Human Health Considerations

Consumer Health Unchanged Unchanged

Worker Safety Unchanged Unchanged

Livestock Health Considerations

Animal Feed (Livestock Health) Unchanged Unchanged

Socioeconomic Considerations

Domestic Economic 

Environment

Unchanged Unchanged

Trade Economic Environment Unchanged Unchanged
Environmental Report Page 31

4. Environmental Consequences

This analysis of potential environmental consequences addresses the potential impact to the human 

environment from the alternatives analyzed in this ER, namely taking no action and a determination by 

the agency that events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 do not pose a plant pest risk 

and therefore should no longer be regulated under 7 CFR Part 340. Potential environmental impacts 

from the No Action Alternative (Alternative I) and the Preferred Action Alternative (Alternative II) are 

described in this section. A cumulative effects analysis is presented for each potentially affected 

environmental concern. Certain aspects of these events and the resultant products would be of no 

concern for either alternative, but could be positive for the environment due to increased processing 

efficiency, effectively increasing yield per acre by reducing culls (out of specification products) due to 

the presence of black spot bruise.

4.1. Scope of Analysis 

Potential environmental impacts from the No Action Alternative (Alternative I) and Determination of 

Nonregulated Status (Alternative II) of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are 

described throughout this section. An impact would be any change, positive or negative, from the 

existing baseline conditions of the affected environment (see Section 2 for overview information). 

Impacts may be categorized as direct, indirect, or cumulative. A direct impact is an effect that results 

solely from a proposed action and occurs at the same time and place, e.g., soil disturbance, air 

emissions, and water use. An indirect impact may be an effect that is related to but removed from a 

proposed action being later in time or farther removed in distance but still reasonably foreseeable, e.g., 

increased field tillage operations negatively impacting water resources through topsoil runoff.

A cumulative effects analysis is also included for each environmental issue. A cumulative impact may be 

an effect to the environment which results from the incremental impact of the action when added to 

other past, present and reasonably foreseeable future actions. An example would be transforming 

potato plants with other GE constructs that are no longer subject to the regulatory requirements of 7 

CFR Part 340 or the plant pest provisions of the Plant Protection Act. If there are no direct or indirect 

impacts, there can be no cumulative impacts.

4.2. Agricultural Production of Potatoes

Land Use 

As discussed in Section 2.2, Agricultural Production of Potatoes: Land Use, potato yields have increased 

dramatically over the years, while acreage devoted to cultivation has declined. Potato acres harvested 

in the U.S. have ranged between 1.0 and 1.5 million acres since 1951, with highs of 1.5 million in 1953, 

1966 and 1967 and lows of 1.0 million in 2008, 2009 and 2010 (USDA NASS 2012). Per-acre yields, which 

averaged 397 CWT per acre in 2011 and 401 CWT per acre in 2010 have increased eight-fold since the 

early 1900s and have doubled since the early 1960s (USDA NASS 2012). 

Alternative I: No Action. USDA projects the potato supply will increase by 4.6% between 2012 and 2021 

(USDA 2012 p. 76). Based upon the historical trends in productivity, this increase in supply is unlikely to 

result in an increase in potato acreage. Therefore, under Alternative I: No Action, agricultural land used 

for potato production is expected to remain essentially as it is now. 
Environmental Report Page 32

Alternative II: Approval of Petition in Whole. If APHIS chooses this alternative, some of the events could 

become commercially available to the general public. Growers who now purchase conventional 

varieties of Russet Burbank, Ranger Russet and Atlantic potato seed would have the option of 

purchasing the InnateTM varieties instead of their conventional counterparts. With the reduction in black 

spot bruising and lower levels of reducing sugars, the Ranger Russet may gain more market share, 

partially replacing the Russet Burbank. The lower levels of reducing sugars in the Atlantic potato may 

result in increased market share for that variety, as well. However, the introduction of these varieties is 

not expected to have an impact on overall demand for potatoes. As described in the petition (Collinge 

and Clark 2013), the agronomic characteristics of the ten events are essentially the same as their 

conventional counterparts, and therefore would be grown in the same way as their conventional 

counterparts. The ten events do not possess traits that would allow them to be grown in areas other 

than those where their conventional counterparts are grown. 

Therefore, no difference from Alternative I: No Action in terms of land use would be expected if the 

petition was approved in whole. 

General Agronomic Practices 

Agronomic practices and major production areas are discussed in Section 2.2, Agricultural Production of 

Potatoes: General Agronomic Practices. Potatoes are grown across the contiguous U.S. and Alaska, with 

major production areas in Idaho, Washington, North Dakota, Minnesota, Wisconsin, Colorado and 

Maine. The majority of the crop is grown using irrigation. Potato production is input-intensive, and 

large-scale production requires specialized equipment.

Alternative I: No Action. If APHIS chooses Alternative I: No Action, general production practices would 

be expected to continue as they are now. 

Alternative II: Approval of Petition in Whole. The agronomic evaluation of the ten events is 

summarized in Section 7 of the petition, with details provided in Appendix 6; analysis of disease 

susceptibility is presented in petition Appendix 8 (Collinge and Clark 2013). Since all ten events are 

intended for fry and chip production, agronomic evaluations were conducted in geographically distinct 

sites that represent most of the main production areas for potatoes destined for fry and chip production 

in the U.S. (Collinge and Clark 2013). The agronomic practices and pest control measures employed 

were location-specific and typical for potato cultivation. They were recommended by both regional 

potato extension specialists and field agronomists including soil preparation, fertilizer application, 

irrigation, cultivation and pesticide-based control methods. Events and untransformed varieties received 

identical inputs and treatments at each site. The following characteristics were evaluated over multiyear trials: time to emergence, vigor, leaf size, leaf curl, vine maturity, disease susceptibility, insect 

damage, yield and specific gravity. These trials indicated that no changes to current agronomic practices 

will be needed to grow the potatoes, thus the incorporated traits are not expected to affect agronomic 

practices. All events considered for deregulation were selected to exhibit comparable phenotypic 

characteristics to the control varieties when grown using standard industry practices. There were no 

differences in disease susceptibility that would require additional treatments, nor did the potatoes have 

different nutrient requirements that would alter fertilizer programs. Planting, cultivation, management 

and harvesting processes were not affected by the incorporated traits.
Environmental Report Page 33

In summary, based on the analysis presented in the petition, no impacts on agronomic practices are 

expected. If APHIS were to choose Alternative II: Approve the Petition in Whole, there would be no 

expected differences for general production practices than if Alternative I: No Action was chosen.

Organic Production Practices 

Organic potato production is discussed in Section 2.2, Agricultural Production of Potatoes: Organic 

Production Practices. The major production states are California, Colorado and Washington. Some 

organic potatoes are grown in the same areas as conventional potatoes and some are grown in more 

isolated regions. Based on USDA data, organic potato acreage from 1997 to 2008 showed a general 

increasing trend ranging from a low of 4,335 acres in 1997 to a high of 11,664 in 2007 (USDA ERS 2009). 

Alternative I: If APHIS chooses the No Action Alternative, organic production is expected to continue 

much the same as it has in the recent past. Many unpredictable variables may affect trends, including 

demand for both fresh and processed organic potatoes, overseas competition and production costs. 

Alternative II: Potato variety selection and breeding practices are similar between organic and 

conventional potato production, as commercial potatoes are predominantly grown from seed potatoes. 

Risks to organic growers would be most likely to occur with accidental mixing of planting material or of 

potatoes in farming, transportation, or processing channels. These risks are the same as those that 

organic growers already experience when keeping their organically grown potatoes separate from 

potatoes grown with conventional methods. Because potatoes are clonally propagated, the risk of 

affecting seed supplies through cross-pollination is negligible. Organic farmers routinely plant organic 

seed potato material and any incidence of cross-pollination in production fields will not affect the 

harvested potatoes. 

In summary, if APHIS were to choose Alternative II: Approval of the Petition in Whole, organic growers 

would not be expected to modify their practices in any way as a result, thus, no impacts to organic 

potato production would be expected. 

4.3. Physical Environment

Water Resources

Water resources are discussed in Section 2.3, Physical Environment: Water Resources. The majority of 

potato production occurs with the use of irrigation. Crop production of any kind, including potatoes, can 

adversely impact water quality, primarily through sedimentation from erosion (surface water) and 

nutrient loading from fertilizers (groundwater). 

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, water withdrawals for 

irrigation would be expected to continue. Supplemental irrigation may increase in some areas where 

potatoes have traditionally been grown without irrigation, and potential for water quality impacts will 

continue. 

Alternative II: Approval of Petition in Whole. As discussed above in Section 4.2, Agricultural 

Production: General Production Practices, the evaluation presented in the petition (Collinge and Clark 

2013) demonstrates that when growing these potatoes no changes will be needed in agronomic 

practices. As discussed in Section 4.2, agronomic practices that could affect water resources, such as 
Environmental Report Page 34

irrigation, cultivation, and pesticide and fertilizer application, were based on practices appropriate for 

each site, and were the same for the ten events and the controls. The results indicated that no changes 

from the site-specific practices used for conventional varieties would be needed for production of the 

ten events. Again, supplemental irrigation may increase in some areas where potatoes have 

traditionally been grown without irrigation, and potential for water quality impacts will continue.

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to 

water resources resulting from this action are expected to be the same as if Alternative I: No Action had 

been chosen.

Soil Quality 

Soil quality, as related to potato production and the potential impacts on soil quality, is discussed in 

Section 2.3, Physical Environment: Soil Quality. The relatively high tillage requirements for a potato crop 

and the small amount of post-crop plant material left in the soil can contribute to increased erosion 

potential. Cover crops are often planted to help mitigate this potential.

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, current potato production 

practices and the associated impacts on the soil are expected to continue. 

Alternative II: Approval of Petition in Whole. As discussed above in Section 4.2, Agricultural 

Production: General Production Practices, the evaluation presented in the petition (Collinge and Clark 

2013) demonstrates that no changes to agronomic practices will be required, including cultivation 

(tillage), for production of any of the ten events. Except for the incorporated traits, the ten events are 

substantially equivalent to their conventional counterparts, thus no changes in plant/soil interaction are 

expected. 

In summary, if APHIS were to choose Alternative II: Approval of Petition in Whole, agricultural impacts 

on soil quality are expected to remain the same as they would if Alternative I: No Action was chosen.

Air Quality

Air quality and the Clean Air Act are discussed in Section 2.3, Physical Environment: Air Quality. 

Emissions associated with crop production include vehicular emissions from the use of farm equipment, 

fugitive dust particles and releases of pesticides. Fugitive dust can arise from fields and unpaved 

roadways and can be generated by disturbance of bare soil through vehicle traffic, harvesting operations 

or wind. These impacts are highly variable across potato growing regions and over time, depending on 

such factors as vehicle type, crop type, utilization of pesticides, method of application, soil type and 

weather conditions. 

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, emissions associated with 

vehicles, fugitive dust particles and pesticides are expected to continue. 

Alternative II: Approval of Petition in Whole. As discussed above in Section 4.2, Agricultural 

Production: General Production Practices, the evaluation presented in the petition (Collinge and Clark 

2013) demonstrates that no changes to agronomic practices will be required to grow the potatoes. As 

discussed in Section 4.1, agronomic practices that could affect air quality, such as soil preparation, 

cultivation, pesticide application and harvesting, were based on practices appropriate for each site, and 
Environmental Report Page 35

were the same for the events and the controls. The results indicated that no changes from the sitespecific practices used for conventional varieties would be needed for production of the ten events. 

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to 

air quality resulting from this action are expected to be the same as if Alternative I: No Action had been 

chosen.

Climate Change 

Agricultural contributions to greenhouse gas emissions are discussed in Section 2.3, Physical 

Environment: Climate Change. In addition to the generation of carbon dioxide and other greenhouse 

gases from agricultural lands and the use of fossil-fueled farm equipment, the primary contribution from 

crop farming is associated with agricultural soil management (fertilizer application and other cropping 

practices which contribute NO2). 

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, practices that contribute to 

greenhouse gas emissions are likely to continue; however, changes in practices to reduce emissions may 

be made in the future, either voluntarily or through future government regulations. 

Alternative II: Approval of Petition in Whole. The evaluation presented in the petition (Collinge and 

Clark 2013) demonstrates that changes in agronomic practices, including practices related to equipment 

operation and agricultural soil management such as fertilizer application would not be required for 

production of the ten events. 

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to 

air quality resulting from this action are expected to be the same as if Alternative I: No Action had been 

chosen.

4.4. Biological Resources

Animal Communities 

As discussed in Section 2.4, Biological Resources: Animal Communities, aside from the animals that may 

be living within an agricultural field, the animal communities most likely to be impacted by crop 

agriculture are those in the surrounding areas; aquatic communities are especially sensitive, and may be 

affected by sedimentation and turbidity from erosion, or by pesticide runoff. 

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, animal communities living 

both within and outside of potato fields are expected to continue to experience impacts similar to the 

current impacts of agriculture.

Alternative II: Approval of Petition in Whole. As discussed in Section 4.2, Agricultural Production: 

General Production Practices, no changes in land use are expected if APHIS chooses Alternative II: 

Approval of Petition in Whole. In addition, the evaluation presented in the petition (Collinge and Clark 

2013) demonstrates that changes in agronomic practices, including practices related to pesticide use 

and erosion mitigation would not be required for production of the ten events. In addition, there are a 

large number of insects that feed on potato leaves and other insects that feed on those pests. Many of 

these insects, including the Colorado potato beetle, potato aphid, European corn borer, potato 
Environmental Report Page 36

leafhopper and potato psyllid are considered pests. The events have not been modified to exhibit any 

pesticidal activities and do not contain pesticide-expressing genes. No differences were observed for 

insects or other animals interacting within the potato ecosystem during the field trials, leading to the 

conclusion that the InnateTM potatoes would have the same impact on other organisms as conventional 

potatoes (Collinge and Clark 2013). 

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to 

animal communities resulting from this action are expected to be the same as if Alternative I: No Action 

was chosen. 

Plant Communities, Gene Flow, and Weediness 

Plant communities are discussed in Section 2.4, Biological Resources: Plant Communities, Gene Flow, and 

Weediness. This discussion focuses on the potential for gene flow with plants from related species. 

These include the two wild potato plant species found in the U.S., S. fendleri (also called S. stoloniferum) 

and S. jamesii, and potential gene flow with other cultivated plants. There are no weed species in the 

U.S. with which potatoes can hybridize.

Because commercial potatoes reproduce vegetatively, gene flow among cultivated varieties is not an 

issue with either seed production or commercial potato production. 

The only threatened or endangered Solanum species are located in Puerto Rico and Hawaii, where 

potatoes are not grown commercially.

 

Field hybridization between cultivated potatoes and the wild potato species S. fendleri and S. jamesii has 

not been observed, in spite of intensive study of wild potatoes in the U.S., and such hybridization is 

highly unlikely for the following reasons (as discussed in Section 2.4):

 There appears to be minimal, if any, geographic overlap. As discussed in Section 2.4, S. fendleri

and S. jamesii grow in isolated patches in mountainous areas of the Southwest at elevations 

over 5,000 feet. Of the states where the wild potatoes have been found, Utah does not have 

commercial potato production, only very small acreages are reported for New Mexico, and the 

area of Texas where wild potatoes are found is in the vicinity of commercial production areas. 

Reported occurrences of these wild species in Colorado are very near the New Mexico border, 

and in mountainous areas. There is some potential for overlap in Arizona, however, the 3,700 

acres of potato production represents 0.000051% of the area of the state. The total area of wild 

potatoes in the U.S. is not known; they grow in isolated colonies that are difficult even for 

experienced researchers to find.

 The most widely grown potato variety, Russet Burbank, is infertile.

 Among fertile varieties of cultivated potatoes, all are almost exclusively self-pollinated, with 

approximately 80 to 100 percent of true seed having been derived from self-pollination. As 

discussed in Section 2.4, an isolation distance of 20 meters is sufficient to prevent crosspollination. S. fendleri is also highly self-pollinated, and populations are genetically 

homogenous. 
Environmental Report Page 37

 Hybridization between cultivated potatoes and S. fendleri and S. jamesii has reportedly been 

achieved only by using specialized laboratory techniques (Love 1994 p. 653), and has never been 

known to occur naturally (US EPA 2011d).

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, the probability of the 

hybridization of cultivated varieties of potato with wild species of potato found within the U.S. would 

still be considered negligible, and any impacts to threatened or endangered species would remain 

similar to what is currently observed.

Alternative II: Approval of Petition in Whole. For the same reasons as described in the Alternative I: No 

Action section above, gene flow among cultivated varieties remains unlikely; there would be no impacts 

to threatened or endangered plant species and hybridization with wild potato species is not expected. 

In this case, if APHIS were to choose Alternative II: Approval of Petition in Whole, the results would be 

no different than if Alternative I: No Action was chosen.

Producers of organic true potato seed (TPS) will be able to protect their seed from the deregulated 

events by ensuring that the seed production fields are sufficiently isolated from commercial potato 

fields containing the events. Potential out-crossing can be prevented by separating fields planted for 

organic TPS production by at least 20 meters from fields planted with these events, as is typical for 

spacing organic potato fields from fields where potatoes are produced with conventional methods 

(Connor and Dale 1996 pp. 505-506).

Microorganisms 

Beneficial and detrimental microorganisms are discussed in Section 2.4, Biological Resources: 

Microorganisms. As noted there, growth of desirable microorganisms is facilitated by the presence of 

organic material and appropriate soil pH.

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, potato crop interactions with 

microorganisms are expected to continue as they are presently.

Alternative II: Approval of Petition in Whole. As discussed in Section 4.2, Agricultural Production: 

General Production Practices, the evaluation presented in the petition (Collinge and Clark 2013) 

demonstrates that changes in agronomic practices, including practices related to soil preparation (which 

may impact soil organic material and pH) and to pesticide application (which may directly impact 

microorganisms), would not be required for production of the ten events. In addition, the ten events 

are substantially similar to their conventional counterparts. The biotech potato plants would therefore 

be expected to have the same interactions with soil microorganisms.

 

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to 

microorganisms resulting from this action are expected to be the same as if Alternative I: No Action was 

chosen.
Environmental Report Page 38

Biodiversity 

General biodiversity and potato biodiversity are discussed in Section 2.4, Biological Resources: 

Biodiversity. As discussed in that section, while modern agricultural crop fields are relatively low in 

biodiversity, the high productivity of modern agriculture results in a smaller footprint for agriculture, 

leaving more land available for biodiversity. Potato biodiversity can be enhanced by the introduction of 

new genetic material from the large number of existing genetic resources available.

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, increases in potato 

productivity are expected to continue to offset increased demand, resulting in a fairly constant acreage 

devoted to potato production in the U.S. (see discussion above Section 4.2, Agricultural Production:

Land Use). This will allow for continued biodiversity outside the borders of agricultural fields. 

Biodiversity is expected to continue to be fairly low within agricultural fields. 

Alternative II: Approval of Petition in Whole. As discussed in Section 4.2, Agricultural Production: Land 

Use, changes in land use are not expected. The evaluation presented in the petition (Collinge and Clark 

2013) demonstrates that changes in agronomic practices would not be required for production of the 

ten events. Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, 

any impacts to biodiversity would be expected to be the same as if Alternative I: No Action was chosen.

If APHIS chooses Alternative II: Approval of Petition in Whole, potato biodiversity will be enhanced by 

the introduction of new genetic material through biotechnology and traditional breeding. 

4.5. Human Health 

Consumer Health 

As discussed in Section 2.5, Human Health: Consumer Health, the potato crop is primarily grown for 

human consumption. U.S. per capita potato consumption is approximately 112 pounds per year. Of this, 

approximately 65 pounds is used for frozen fries or chips. Per capita consumption data are shown in 

Table 6. As discussed in Section 2.5, potential toxins in potatoes are acrylamide (after cooking) and 

glycoalkaloids; patatin is an allergen for a very small percent of children. 

Alternative I: No Action. Under this alternative, consumption of potatoes would be expected to 

continue much as it is currently. Consumers will continue to be exposed to similar levels of acrylamide 

in cooked potatoes if other methods are not employed to reduce levels. Glycoalkaloids would be 

expected to remain at sufficiently low levels such that health impacts would not occur. Patatin would 

remain a concern for those with the allergy.

 

Alternative II: Approval of Petition in Whole. The compositional analyses of the ten events are 

summarized in the petition, with detailed results in Appendix 9 (Collinge and Clark 2013). The 

compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, crude fiber, 

carbohydrate and calories; 2) vitamins B6, B3 and C; 3) minerals copper, magnesium and potassium; 4) 

glycoalkaloids; 5) free amino acids; and 6) total amino acids for tubers collected from events grown in 

2009, 2010, and 2011 in potato-growing areas of the United States. Observed changes in ASN and 

reducing sugars accomplished through transformation of various potato varieties resulted in lower 

acrylamide levels in french fries and potato chips. These modifications did not alter the quality of potato 

as food because all results fell within normal ranges for potato. However, compared with the 
Environmental Report Page 39

conventional varieties, InnateTM potatoes contained, on average, 58 to 72 percent less acrylamide when 

cooked (Collinge and Clark 2013). Approval followed by widespread adoption of these potatoes could 

result in a significant reduction in dietary intake of acrylamide. In addition, the research confirmed that 

glycoalkaloid levels were unchanged compared with the control varieties. 

The National Academy of Sciences (NAS) has ranked methods of genetic modification according to the 

relative likelihood of unintended effects, such as the increase in a plant’s production of certain allergens. 

The NAS considered methods that involve recombinant DNA via Agrobacterium transfer of genes from 

closely related species (the InnateTM method used to produce these 10 events is one such method that 

doesn’t involve the transfer of genes) to be among the methods least likely to have unintended effects –

less likely than conventional pollen-based crossing of closely related species – and far less likely than 

methods such as ionizing radiation and chemical mutagenesis, which are not subject to regulation and 

are not excluded methods under the NOP (National Academy of Sciences 2004 p. 2). 

The potato events described in this petition are no different compositionally compared to 

untransformed controls, except for the intended traits. Therefore, issues with allergies would not be 

expected to exist beyond what individuals with potato allergies would normally experience. 

If APHIS were to choose Alternative II: Approval of Petition in Whole, and with the adoption of the 

potato events, consumers would likely be exposed to lower levels of acrylamide, a naturally-occurring 

substance found to cause cancer in laboratory animals (NTP 2012). In conclusion, the data presented in 

the petition shows that the potato events are at least as safe and nutritious for food as the 

untransformed controls. 

Worker Safety 

As summarized in Section 2.5, Human Health: Worker Health, farm workers are exposed to hazards 

associated with farm equipment and with pesticides, and are protected by the US EPA’s WPS. 

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, farm workers would continue 

to be exposed to the same kinds of hazards as they are currently. 

Alternative II: Approval of Petition in Whole. As discussed in Section 2.9, Typical Agronomic Practices,

the evaluation presented in the petition (Collinge and Clark 2013) demonstrates that changes in 

agronomic practices - including practices involving farm equipment use such as planting, harvesting and 

cultivating, and practices involving pesticide use would not be required for production of the ten events. 

Based on these results, if APHIS were to choose Alternative II: Approval of Petition in Whole, impacts to 

worker health resulting from approval of the petition are expected to be the same as if Alternative I: No 

Action was chosen. 

4.6. Animal Feed

As discussed in Section 2.6, Animal Feed (Livestock Health), a small portion of the potato crop and waste 

from processing are sold as livestock feed. 

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, a small percent of the potato 

crop would continue to be used for livestock feed.
Environmental Report Page 40

 

Alternative II: Approval of Petition in Whole. The compositional analyses of the ten events are 

summarized in Section 8 of the petition, with detailed results in Appendix 9 (Collinge and Clark 2013). 

These results are summarized in the discussion of Human Health in section 4.5. 

In conclusion, the data presented in the petition shows that potatoes from the events are as safe and 

nutritious for feed as the untransformed controls, and if APHIS were to choose Alternative II: Approval 

of Petition in Whole, the use of potatoes as livestock feed would be no different than if Alternative I: No 

Action was chosen.

4.7. Socioeconomic Impacts

Domestic Economic Environment 

The domestic economic environment is discussed in Section 2.7, Socioeconomic: Domestic Economic 

Environment, and potato utilization in the U.S. is summarized in Table 7. Potatoes are grown on 

approximately 1.1 million acres in the U.S., with an annual value of approximately $3.5 billion. Major 

products include fresh potatoes, frozen fries and chips. Organic potatoes account for less than one 

percent of the market.

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, domestic potato production, 

including organic production, is expected to continue at rates similar to the present. The USDA projects 

an approximate 4.6% increase in production between 2012 and 2021 (USDA 2012 p. 76). 

Alternative II: Approval of Petition in Whole. If APHIS were to choose Alternative II: Approval of 

Petition in Whole, the ten events will become available for commercial production. Potatoes with low 

acrylamide potential and reduced black spot bruise are expected to have higher market value for the 

same inputs, representing potential increased revenue for growers and processors, and an overall 

increase in the value of potato production. The initial crop introduction will build up slowly as seed 

becomes available and will be controlled within existing processing channels to ensure that potatoes 

enter only the intended markets. This will provide a period of time to assess consumer acceptance and 

to address grower and industry concerns. A limited introduction that is initially in a vertically integrated 

supply chain will be well controlled by grower and processor agreements. In this situation, conventional 

products will be considered “identity preserved” with respect to the well-controlled stewardship of the 

potato event(s) and its products. As adoption of the potato events increases, programs for identity 

preservation will be implemented as needed. It is expected that development and implementation of 

identity preservation systems will add some cost to the supply chain; the total costs will depend upon 

the type and extent of market penetration (Collinge and Clark 2013). 

Regarding consumer acceptance, studies have found that consumers are likely to be willing to pay a 

premium for a healthier food product (such as reduced acrylamide) developed by methods of 

biotechnology (Huffman 2010 p. 24; Colson et al. 2011 pp. 355-357). 

Overall, if APHIS chooses Alternative II: Approval of Petition in Whole, the introduction of these potato 

events may have positive economic impacts, recognizing that some additional costs could be incurred, 

and as discussed in Section 4.1, no impacts on organic production are expected. 

Trade (International) Economic Environment 
Environmental Report Page 41

As discussed in Section 2.7, Socioeconomic: Trade Economic Environment, the U.S. exports more than $1 

billion in potato products annually, primarily consisting of frozen fries and other processed potatoes. 

Demand from Canada, Mexico and Asia is driving growth in exports. Japan is the largest market for U.S. 

exports of frozen potatoes, while Canada is the largest U.S. export market for chips and fresh potatoes. 

The U.S. also has substantial imports of potatoes and potato products from Canada and Mexico (USDA 

ERS 2012c, p. 19). 

Alternative I: No Action. If APHIS were to choose Alternative I: No Action, U.S. potato exports are 

expected to continue.

Alternative II: Approval of Petition in Whole. If APHIS were to choose Alternative II: Approval of 

Petition in Whole, U.S. potato exports are expected to continue. Approval for the events will be sought 

in Canada, Japan and Mexico (Collinge and Clark 2013) prior to commercial production beginning in the 

U.S. 

Previous recalls of potato products that were shipped to Japan and then found to contain genetically 

modified material were related to unapproved events; Japan has zero tolerance for unapproved events 

(Japan Times 2001, BBC 2001, Hur 2001). To assist in the prevention of trade disruptions, as has been 

experienced with other potato events, international approvals will be pursued from key trading partner 

countries prior to beginning commercial production in the U.S. Simplot intends to follow the 

recommended stewardship policy statement released by the Biotechnology Industry Organization in 

May 2007: 

To help ensure the continued adoption of agricultural biotechnology globally and to continue to 

have products of agricultural biotechnology bring value to the marketplace, BIO’s Food and 

Agriculture Section supports actions that facilitate the flow of goods in commerce and minimize 

trade disruptions. BIO’s Food and Agriculture Section believes that henceforth individual 

member companies should, prior to commercialization meet applicable regulatory requirements 

in key countries identified in a market and trade assessment that have functioning regulatory 

systems and are likely to import the new biotechnology-derived plant products.

The voluntary guideline was adopted because, according to BIO “asynchronous authorizations combined 

with importing countries maintaining ‘zero tolerance’ for recombinant-DNA products not yet authorized 

results in the potential for major trade disruptions. The potential occurrences of trade disruptions will 

only increase given the substantial amount of research that will bring many new products and 

combinations of products to market.”

In addition, compared to some biotech crops, the InnateTM potatoes are expected to be viewed more 

favorably by regulatory organizations due to the lack of pesticidal traits and marker-free transformation 

methods, and therefore have fewer implications for export markets. In any case, these approvals should 

ensure continued trade with key export markets. 

If APHIS were to choose Alternative II: Approval of Petition in Whole, as with the domestic economic 

environment, the introduction of these potato events may have positive economic impacts on export 

markets, recognizing that some additional costs could be incurred. Impacts to export markets will be 

mitigated by approvals in key trading countries such as Japan, Canada, and Mexico.
Environmental Report Page 42

5. CUMULATIVE IMPACTS

Regulations promulgated by the Council on Environmental Quality (CEQ) under the National 

Environmental Policy Act (NEPA) define cumulative impact as “the impact on the environment which 

results from the incremental impact of the action when added to other past, present and reasonably 

foreseeable future actions” (40 CFR 1508.7). For example, the potential effects associated with a 

determination of nonregulated status of a GE crop in combination with the future production of crop 

plants with multiple traits that are no longer subject to the regulatory requirements of 7 CFR Part 340 or 

the plant pest provisions of the Plant Protection Act, including disease tolerance, nitrogen utilization, 

and herbicide tolerance, would be considered a cumulative impact.

As detailed in Section 4, Environmental Consequences, Alternative II: Approval of Petition in Whole is not 

expected to result in any adverse impacts to any resources beyond those that would occur in the 

absence of approval of the petition (Alternative I: No Action). Therefore, if APHIS were to choose 

Alternative II: Approval of Petition in Whole, there will be no additional contributions to cumulative 

impacts, and no discussion of cumulative impacts is needed. 

5.1. Assumptions Used for Cumulative Impacts Discussion

InnateTM potatoes will be cultivated to meet the needs of the consumer, grower, and processor, offering 

protection against black spot bruise, slight changes in reducing sugars, and reduced acrylamide 

potential. During processing, potatoes are routinely culled out due to black spot bruise when making 

french fries or potato chips, however, with InnateTM potatoes, fewer potatoes will be lost to black spot 

bruise, resulting in less waste. As a result, there could be increases in yield, with associated positive 

environmental impacts related to land use and agricultural inputs. For the purposes of the cumulative 

impacts discussion, however, it is assumed conservatively that land use and inputs would potentially 

decline or remain the same, and are unlikely to increase. Additionally, reduced levels of acrylamide in 

cooked potatoes will benefit the general public, by reducing levels of this compound that has been 

linked to cancer in laboratory animals (NTP 2012). 

In the future, additional biotech traits could be added to the InnateTM potatoes. After APHIS reaches a 

determination of nonregulated status, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 would 

no longer be subject to the requirements of 7 CFR Part 340 and the plant pest provisions of the Plant 

Protection Act. When additional traits are added to these events, the new varieties would be evaluated 

by APHIS only as related to the new unapproved traits. 

5.2. Cumulative Impacts: Land Use

Cumulative effects in land use resulting from a determination of nonregulated status of events E12, E24, 

F10, F37, J3, J55, J78, G11, H37, and H50 are unlikely. With the reduction in black spot bruising, lower 

levels of reducing sugars, and reduced acrylamide potential, the InnateTM potatoes may gain more 

market share, partially replacing other varieties. However, the introduction of these varieties is not 

expected to have an impact on overall demand for potatoes. With the public acceptance of biotech 

potatoes, additional traits could be added that would benefit the farmers, processors, and consumers. 

Also, even if the new traits provide environmental, economic or health benefits, they are unlikely to 

alter the market demand for potatoes, and thus will not lead to significant changes in land used for 

potato production. In conclusion, land use is expected to stay the same for InnateTM and conventional 

potatoes and no cumulative impacts result. 
Environmental Report Page 43

5.3. Cumulative Impacts: General Agronomic Practices

Cumulative impacts of general agronomic practices for events E12, E24, F10, F37, J3, J55, J78, G11, H37, 

and H50 are expected to be the same as conventional potatoes. Potatoes referred to as InnateTM have no 

additional insecticidal, miticidal, fungicidal, or herbicide tolerance activity and do not require additional 

or different agricultural inputs as shown by the plant characterization data in the Simplot Submission, 

when compared to the applicable controls. 

As shown in the multi-year field trial data for agronomic and phenotypic characterizations, no additional 

agricultural inputs were required compared to conventional potatoes. No significant differences were 

observed that would indicate an increase in agricultural inputs such as fertilizer, herbicides, insecticides, 

miticides, and fungicides throughout the duration of the field trials. In conclusion, general agronomic 

practices are expected to stay the same for InnateTM and conventional potatoes and no cumulative 

impacts result. 

5.4. Cumulative Impacts: Organic Production Practices

Cumulative impacts on organic production practices concerning events E12, E24, F10, F37, J3, J55, J78, 

G11, H37, and H50 are expected to be the same as with conventional potatoes. As shown in the multiyear field trial data, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 potatoes do not grow any 

differently or have altered gene flow characteristics when compared to conventional potatoes. In the 

unlikely event that gene flow did happen between InnateTM and organically produced potatoes, the 

organic tubers would not be impacted because gene flow would impact seed, not the tubers sold 

commercially. In conclusion, InnateTM potatoes pose no more risk to organic growers than conventional 

potatoes and no cumulative impacts would result from the approval of the petition for InnateTM 

potatoes.

5.5. Cumulative Impacts: Water Resources

Cumulative impacts to water resources would be expected to be the same for events E12, E24, F10, F37, 

J3, J55, J78, G11, H37, and H50 and conventional potatoes. As discussed in Section 2.3, agricultural 

production in general, including potatoes, can adversely impact surface water quality primarily through 

sedimentation from erosion and nutrient loading from fertilizers. And, as previously discussed in Section 

4.2, agronomic practices that could affect water resources such as irrigation, cultivation, and pesticide 

and fertilizer application, were based on practices appropriate for each geographic location and were 

the same for InnateTM and conventional potatoes. Therefore, cumulative impacts to water resources of 

InnateTM potatoes will be the same as conventional potatoes.

5.6. Cumulative Impacts: Soil Quality

Cumulative impacts to soil quality would be expected to be the same for events E12, E24, F10, F37, J3, 

J55, J78, G11, H37, and H50 and conventional potatoes. As discussed in section 2.3, potatoes can be 

grown in a wide range of soil types and require more tillage than some other crops due to the irrigation 

and harvesting methods used in potatoes. U.S. potato production in general utilizes soil tillage 

operations to prepare the soil, practice mechanical weed control (particularly organic production), and 
Environmental Report Page 44

harvest the potatoes. In conclusion, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are 

expected to have the same cumulative impacts on soil quality as conventional potatoes.

5.7. Cumulative Impacts: Air Quality

Cumulative impacts to air quality would be expected to be the same for events E12, E24, F10, F37, J3, 

J55, J78, G11, H37, and H50 and conventional potatoes. As discussed in Section 2.3, air quality can be 

reduced by many agricultural operations including using a tractor for field operations that produce dust 

and emissions from the combustion of fossil fuels for mechanized agricultural equipment use. Air quality 

is expected to stay constant with respect to different agronomic practices, but will likely be reduced in 

the future due to advances in technology, e.g., lower emission diesel fuel that can be used in tractors 

and other farm equipment. In conclusion, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 will 

have the same cumulative impacts on air quality as conventional potatoes.

5.8. Cumulative Impacts: Climate Change

Cumulative impacts due to climate change would be the same for events E12, E24, F10, F37, J3, J55, J78, 

G11, H37, and H50 and conventional potatoes. As discussed in Section 2.3, potato production and 

agriculture in general may contribute to climate change, if it occurs, as a result of the generation of 

carbon dioxide and other greenhouse gases resulting from agricultural production. Potato production in 

the United States has a fairly small production footprint (approximately 1 million acres, USDA NASS 

2012) when compared to row crops like corn (approximately 97 million) and soybeans (approximately 86 

million acres). Considering the production acres, potatoes, including the InnateTM varieties, will have less 

impact on climate change than the higher acreage crops. In conclusion, events E12, E24, F10, F37, J3, 

J55, J78, G11, H37, and H50 are expected to have the same cumulative impacts on climate change as 

conventional potatoes.

5.9. Cumulative Impacts: Animal Communities

Cumulative impacts to animal communities would be the same for events E12, E24, F10, F37, J3, J55, 

J78, G11, H37, and H50 and conventional potatoes. Three years of field data as well as compositional 

analysis and molecular stability show that events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 are 

equivalent to conventional potatoes. Even in cases where asparagine was lower (for reducing 

acrylamide), the levels were still within the combined literature ranges. In addition, no changes were 

observed in land use or agronomic inputs including pesticides. These data show that there is the same 

impact (and expected cumulative impacts) on non-target animals or animal communities within the 

potato agroecosystem for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 as the conventional 

potatoes. 

5.10. Cumulative Impacts: Plant Communities, Gene Flow, and Weediness

Cumulative impacts to plant communities resulting from gene flow or weediness potential would be the 

same for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes. Multiple 

years of field data as well as compositional analysis show that events E12, E24, F10, F37, J3, J55, J78, 

G11, H37, and H50 and are equivalent to conventional potatoes. Also, no changes were observed in land 

use or agronomic inputs including pesticides and herbicides. Gene flow from potatoes whether biotech 

or conventional is unlikely due to the cropping practices of rotation and the clonal propagation of potato 
Environmental Report Page 45

varieties in U.S. agriculture. Additionally as described in the Simplot Submission and in Section 2 of this 

ER, conventional potatoes and events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 show no 

apparent weediness. As a result, events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50, like 

conventional potatoes, would grow poorly outside of cultivation. While there is some potential for 

volunteer potatoes to grow, it would be the same for the events and controls. Potato growing methods 

include rotation and other agronomic practices to minimize the impact of volunteers in both 

conventional and InnateTM potato production. In conclusion, events E12, E24, F10, F37, J3, J55, J78, G11, 

H37, and H50 are expected to have the same cumulative impacts on plant communities as conventional 

potatoes.

5.11. Cumulative Impacts: Microorganisms

Cumulative impacts to microorganisms are expected to be the same for events E12, E24, F10, F37, J3, 

J55, J78, G11, H37, and H50 and conventional potatoes. Microorganisms are a diverse group of 

organisms that flourish in and around agricultural cropping systems. Microorganisms include everything 

from pathogens to symbiotic bacteria to decomposers within the various trophic levels of the potato 

agroecosystem. Data presented in the Simplot Submission show that no significant impacts were 

observed in multiple years of field data (agronomic and phenotypic characteristics and ecological 

interactions), disease assays conducted in the field and laboratory, as well as compositional equivalence 

studies. Therefore cumulative impacts of events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 to 

microorganisms are expected to be the same as conventional potatoes.

5.12. Cumulative Impacts: Biodiversity

Cumulative impacts to biodiversity would be expected to be the same for events E12, E24, F10, F37, J3, 

J55, J78, G11, H37, and H50 and conventional potatoes. InnateTM and conventional potatoes were shown 

to be substantially equivalent based on multiple years of field data, disease assays conducted in the field 

and laboratory, as well as compositional equivalence studies. Therefore, InnateTM and conventional 

potatoes responded similarly in all studies and would have a similar cumulative impact on biodiversity. 

5.13. Cumulative Impacts: Consumer Health

Cumulative effects on consumer health are expected to be the same for events E12, E24, F10, F37, J3, 

J55, J78, G11, H37, and H50 and conventional potatoes, with one exception: The InnateTM potatoes 

contain significantly less acrylamide forming potential than conventional potatoes. The Simplot 

Submission discusses consumer health and the relevance for acrylamide, glycoalkaloids, and patatin in 

potatoes.

Reductions in ASN and reducing sugars resulted in lower acrylamide levels in french fries and potato 

chips. These modifications did not alter the quality of potato as food because all results fell within 

normal ranges for potato. Compared with the conventional varieties, InnateTM potatoes contained on 

average 58 to 72 percent less acrylamide (Collinge and Clark 2013). Adoption of these potatoes could 

result in a significant reduction in dietary intake of acrylamide and decrease exposure to this naturally 

occurring substance found to cause cancer in laboratory animals (NTP 2012). 

In addition, the research confirmed that glycoalkaloid levels were unchanged compared with the control 

varieties. Although patatin was not measured during the studies, total protein did not differ between 

InnateTM and conventional potatoes and it was concluded that any potential allergy to patatin would be 
Environmental Report Page 46

the same. In conclusion, cumulative impacts of the InnateTM potatoes could positively affect human 

health with a reduction in acrylamide exposure and the InnateTM potatoes are expected to have the 

same levels of glycoalkaloids and patatin as conventional potatoes. 

5.14. Cumulative Impacts: Worker Safety

Cumulative impacts to worker safety would be expected to be the same for events E12, E24, F10, F37, 

J3, J55, J78, G11, H37, and H50 and conventional potatoes. The multi-year field trials showed no 

differences in plant phenotype and no additional agricultural inputs were required compared to 

conventional potatoes. It was concluded that no change in agricultural inputs such as fertilizer, 

herbicides, insecticides, miticides, and fungicides was needed between InnateTM and conventional 

potatoes. As a result, since farming practices are expected to remain the same, cumulative impacts on 

worker safety would be the same whether growing InnateTM or conventional potatoes.

5.15. Cumulative Impacts: Animal Feed (Livestock Health)

Cumulative impacts to livestock health from potatoes used as feed would be expected to be the same 

for events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes. The 

compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, crude fiber, 

carbohydrate and calories; 2) vitamins B6, B3 and C; 3) minerals copper, magnesium and potassium; 4) 

glycoalkaloids; 5) free amino acids; and 6) total amino acids. Although some differences were observed, 

all results fell within the normal range for potato and it was concluded that food quality would be the 

same for InnateTM and conventional potatoes. 

In addition, the research confirmed that glycoalkaloid levels were unchanged compared with the control 

varieties. Although patatin was not measured during the studies, total protein did not differ between 

InnateTM and conventional potatoes and it was concluded that any potential allergy to patatin would be 

the same. In conclusion, cumulative impacts of the InnateTM potatoes would be the same as 

conventional potatoes since all nutrients fell within normal levels for potato. In addition, InnateTM 

potatoes are expected to have the same levels of glycoalkaloids and patatin as conventional potatoes. 

5.16. Cumulative Impacts: Domestic Economic Environment

Cumulative impacts on the domestic economic environment would be similar for events E12, E24, F10, 

F37, J3, J55, J78, G11, H37, and H50 and conventional potatoes, although some economic impact is 

expected because of the benefits of the new potatoes. These events grow similarly and have similar 

biochemical composition to conventional potatoes, however, the low acrylamide, reducing sugars, and 

black spot bruise traits add value that could increase the price received for these potatoes. Potatoes 

with low acrylamide potential and reduced black spot bruise are expected to have higher market value 

for the same inputs, representing potential increased revenue for growers and processors, and an 

overall increase in the value of potato production. 

Consumer and market acceptance will be required for the InnateTM potatoes to gain significant market 

share. Widespread adoption of other biotech crops should lead to similar adoption of potatoes, 

especially with the addition of traits that provide health benefits (reduced acrylamide potential) for 

consumers and quality improvements (low black spot bruise and reduced levels of reducing sugars) for 

processors. Additionally, potatoes are often processed into fries and chips which already utilize 

biotechnology derived foods such as high oleic oils.
Environmental Report Page 47

Introduction of InnateTM potatoes will require channeling of the new potatoes into the desired markets. 

The careful supply chain introduction would be similar to all potato variety management systems 

already in place for product purity. It is expected that development and implementation of identity 

preservation systems will add some cost to the supply chain; the total costs will depend upon the type 

and extent of market penetration (Collinge and Clark 2013). In conclusion, the InnateTM potatoes could 

have cumulative economic impacts on the domestic potato market, public acceptance will be learned 

after approval, and procedures will be developed to manage product purity in the supply chain.

5.17. Cumulative Impacts: Trade (International) Economic Environment

Cumulative impacts to the trade economic environment would be similar for events E12, E24, F10, F37, 

J3, J55, J78, G11, H37, and H50 and conventional controls, although some economic impact is expected 

because of the benefits of the new potatoes. The U.S. exports more than $1 billion in potato products 

annually, primarily consisting of frozen fries and other processed potatoes. Japan is the largest market 

for U.S. exports of frozen potatoes, while Canada is the largest U.S. export market for chips and fresh 

potatoes. 

Introduction of InnateTM potatoes will require channeling of the new potatoes into the desired markets, 

and avoidance of those who chose not to use the new potatoes. The careful supply chain introduction 

would be similar to all potato variety management systems already in place for product purity. It is 

expected that development and implementation of identity preservation systems will add some cost to 

the supply chain; the total costs will depend upon the type and extent of market penetration (Collinge 

and Clark 2013).

Upon introduction, procedures will be implemented to prevent unintended mixing of InnateTM with 

conventional potatoes as part of the stewardship program. In addition, Simplot is seeking international 

regulatory approvals in areas such as Japan and Mexico for import approval. Also, approval in Canada is 

being sought for import and cultivation. Approval in these key trading countries will minimize market 

disruption should a low level presence of InnateTM potatoes be found in the market from accidental 

mixing. In conclusion, the InnateTM potatoes could have cumulative trade economic impacts on the 

potato export market and procedures will be developed to manage product purity in the supply chain.
Environmental Report Page 48

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